# facilities

fei_number: 3032871131
facility_name: SHOBHA LIFE SCIENCES PRIVATE LIMITED
facility_name_normalized: shobha life sciences private
city: 137/A2
state: 137/AA
country: 137/RU
registrant_name: SHOBHA LIFE SCIENCES PRIVATE LIMITED
business_operations: API MANUFACTURE
business_address:
Sy.Nos.137/EE,137/A2,137/AA,137/U/1,137/RU,137/U/2,138/U/2,139/A1/2, and 141/AA1/2, Pittampally Village, Nalgonda District, Chityala Mandal,, Chityala, Telangana, 508114, IND


fei_number: 3008763840
facility_name: SITEC LABS LIMITED
facility_name_normalized: sitec labs
city: TTC Industrial Area
state: MIDC
country: Near NELCO Bus Stop
registrant_name: SITEC LABS LIMITED
business_operations: API/FDF ANALYTICAL TESTING
business_address:
Plot No. Gen 40 and PAP-A-417, TTC Industrial Area, MIDC, Behind Millennium Business Park, Near NELCO Bus Stop, Mahape, Navi Mumbai, Maharashtra, 400710, IND


fei_number: 3028790835
facility_name: STHREE CHEMICALS PRIVATE LIMITED
facility_name_normalized: sthree chemicals private
city: Sipcot Industrial Complex
state: Phase-111
country: Ranipet
registrant_name: STHREE CHEMICALS PRIVATE LIMITED
business_operations: API MANUFACTURE
business_address:
Plot No. S-117 to S120, Sipcot Industrial Complex, Phase-111, Sipcot Mugundaryapuram, Ranipet, TN, 632405, IND


fei_number: 3030355960
facility_name: SURAJ LABORATORIES PRIVATE LIMITED
facility_name_normalized: suraj laboratories private
city: 540/4
state: 540/5
country: Hobli
registrant_name: SURAJ LABORATORIES PRIVATE LIMITED
business_operations: API MANUFACTURE
business_address:
Plot no. 540/3P1, 540/4, 540/5, KIADB Kadechur-Badiyal Industrial area, Hobli, Saidapur, Yadgir, Karnataka, 585221, IND


fei_number: 3003600340
facility_name: SYNGENE INTERNATIONAL LIMITED
facility_name_normalized: syngene international
city: Biocon Park
state: Plot No 2
country: 4 & 5
registrant_name: Syngene International Limited
business_operations: API MANUFACTURE
business_address:
Biocon SEZ, Biocon Park, Plot No 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka, 560099, IND


fei_number: 3035152598
facility_name: SYNGENE INTERNATIONAL LIMITED
facility_name_normalized: syngene international
city: No: 68/A
state: Bommasandra Industrial Area
country: Hosur Road
registrant_name: Syngene International Limited
business_operations: API MANUFACTURE
business_address:
Unit 3, No: 68/A, Bommasandra Industrial Area, I Phase, Hosur Road, Anekal, Bengaluru, Karnataka, 560099, India


fei_number: 3006398900
facility_name: Sai Life Sciences Limited
facility_name_normalized: sai life sciences
city: Plot No. 78C
state: 79A
country: 80-A
registrant_name: Sai Life Sciences Limited
business_operations: API MANUFACTURE
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
Unit IV, Plot No. 78C, 79A, 79B, 80-A, 80-B, 81-A, 82, Sy. No. 280, Kolhar Industrial Area, Bidar, Karnataka, 585403, India


fei_number: 3032546867
facility_name: ScieGen Pharmaceuticals India Private Limited
facility_name_normalized: sciegen pharmaceuticals india private
city: 418 to 433 & 434 Plot No. 10
state: 11
country: 13 & 14 TSIIC
registrant_name: ScieGen Pharmaceuticals India Private Limited
business_operations: FDF MANUFACTURE
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
SY. No. 408 to 412, 418 to 433 & 434 Plot No. 10,11,12,13 & 14 TSIIC, GIP, Polepally(V), Jadcherla,, Mahabubnagar, Telangana, 509302, IND


fei_number: 3003666337
facility_name: Seratec
facility_name_normalized: seratec
city: Courville Sur Eure
state: Centre Val De Loire
country: FRA
registrant_name: Seratec
business_operations: API MANUFACTURE
business_address:
Villages Des Enterprises 2 Rue Du Thymerais Rte BillancelRte Billancel, Courville Sur Eure, Centre Val De Loire, 28190, FRA


fei_number: 3009432595
facility_name: Sichuan D- Innovation Pharmaceutical Co., Ltd.
facility_name_normalized: sichuan d- innovation pharmaceutical
city: Yulan Road
state: Western Medica Valley
country: Economic Development Zone
registrant_name: Sichuan D- Innovation Pharmaceutical Co., Ltd.
business_operations: API MANUFACTURE
business_address:
No. 13, Yulan Road, Western Medica Valley, New Zone, Economic Development Zone, Meishan, Meishan, 620000, CHN


fei_number: 3014500199
facility_name: Sichuan Huiyu Pharmaceutical Co., Ltd. Second Branch
facility_name_normalized: sichuan huiyu pharmaceutical co., ltd. second branch
city: Shizhong District
state: Nejjiang
country: China (CHN)
registrant_name: Sichuan Huiyu Pharmaceutical Co., Ltd.
business_operations: API MANUFACTURE
business_address:
No. 2003 Hanyang Road, Shizhong District,Nejjiang, Sichuan 641000, China (CHN), Neijiang, Sichuan, 641000, CHN


fei_number: 3016946731
facility_name: Sichuan Renan Pharmaceutical Co., Ltd
facility_name_normalized: sichuan renan pharmaceutical
city: Renan Section
state: Health Road
country: Yuechi
registrant_name: Sichuan Renan Pharmaceutical Co., Ltd
business_operations: API MANUFACTURE
business_address:
No.9, Renan Section, Health Road, Jiulong Town (Industrial Park), Yuechi,, Guangan, Sichuan, 638300, CHN


fei_number: 3008127341
facility_name: Sidmak Laboratories (India) Private Limited
facility_name_normalized: sidmak laboratories (india) private
city: Pharma City
state: Selaqui Industrial Area
country: Dehradun - 248011
registrant_name: Sidmak Laboratories (India) Private Limited
business_operations: FDF MANUFACTURE
business_address:
Plot No. 20, Pharma City, Selaqui Industrial Area, Vikas Nagar, Dehradun - 248011, Uttarakhand, India, Dehradun, , 248011, IND


fei_number: 3012696012
facility_name: Simson Life Sciences Private Limited
facility_name_normalized: simson life sciences private
city: TYPE III
state: TSIIC
country: PRASHANTHI NAGAR
registrant_name: Simson Life Sciences Private Limited
business_operations: API/FDF ANALYTICAL TESTING
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
SHED NO 6A, TYPE III, TSIIC, IE, PRASHANTHI NAGAR, KUKATPALLY HYDERABAD, Medchal - Malkajgiri, Telangana, 500072, Hyderabad, Telangana, 500072, IND


fei_number: 3008590267
facility_name: Spinos Life Science and Research Private Limited
facility_name_normalized: spinos life science and research private
city: Krishna Madura Vanam
state: Vellakinar Pirivu
registrant_name: Ramapalaniappan Abiraamasundari
business_operations: CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
Door No.29 A, Krishna Madura Vanam, Vellakinar Pirivu, Thudiyalur,, Coimbatore, Tamil Nadu, 641029, IND


fei_number: 3005151016
facility_name: Strides Pharma Science Limited
facility_name_normalized: strides pharma science
city: SIDCO Pharmaceutical Complex
state: Alathur
country: Tamil Nadu
registrant_name: Strides Pharma Science Limited
business_operations: API/FDF ANALYTICAL TESTING
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
Plot No. 101 to 108 & 153, SIDCO Pharmaceutical Complex, Alathur, Chengalpattu, Tamil Nadu, 603110, IND


fei_number: 3010634351
facility_name: Synergene Active Ingredients Private Limited
facility_name_normalized: synergene active ingredients private
city: Plot No.59-D
state: Jawaharlal Nehru Pharma City
country: Anakapalli District
registrant_name: Phani Kumar
business_operations: API MANUFACTURE
business_address:
Unit-II, Plot No.59-D, Jawaharlal Nehru Pharma City, Parawada (V & M), Anakapalli District, Anakapalli, Andhra Pradesh, 531021, IND


fei_number: 3003227156
facility_name: Tianish Laboratories Private Limited
facility_name_normalized: tianish laboratories private
city: Plot No. 14
state: 99 & 100
country: Patancheru
registrant_name: Tianish Laboratories Private Limited
business_operations: API MANUFACTURE
business_address:
(Unit-7), Plot No. 14, 99 & 100, IDA Pashamylaram Phase-II, Patancheru, Sangareddy District, Hyderabad, Telangana, 502307, IND


fei_number: 3004713397
facility_name: Tianish Laboratories Private Limited
facility_name_normalized: tianish laboratories private
city: Survey No.10/42
state: Gaddapotharam
country: Sangareddy District
registrant_name: Tianish Laboratories Private Limited
business_operations: API MANUFACTURE
business_address:
(Unit-1 & Unit-2), Survey No.10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy District, Hyderabad, Telangana, 502319, IND


fei_number: 3008861594
facility_name: Tianish Laboratories Private Limited
facility_name_normalized: tianish laboratories private
city: Plot No. 5
state: Road No.12
country: Parawada Mandal
registrant_name: Tianish Laboratories Private Limited
business_operations: API MANUFACTURE
business_address:
(Unit-9), Plot No. 5, Road No.12, Jawaharlal Nehru Pharma City Tadi Village, Parawada Mandal, Anakapalli, Andhra Pradesh, 531019, IND


fei_number: 3009590042
facility_name: Tianish Laboratories Private Limited
facility_name_normalized: tianish laboratories private
city: Plot No. 86
state: Ramky Pharma City (India) Ltd SEZ
country: Parawada Mandal
registrant_name: Tianish Laboratories Private Limited
business_operations: API MANUFACTURE
business_address:
(Unit-10), Plot No. 86, Ramky Pharma City (India) Ltd SEZ, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli, Andhra Pradesh, 531019, IND


fei_number: 3003647459
facility_name: Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.)
facility_name_normalized: unique pharmaceutical laboratories (a division of j. b. chemicals & pharmaceuticals ltd.)
city: Daman Industrial Estate
state: Airport Road
country: Daman
registrant_name: Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.)
business_operations: API/FDF ANALYTICAL TESTING
business_address:
Survey No.101/2 & 102/1, Daman Industrial Estate, Airport Road, Kadaiya, Daman, Dadra & Nagar Haveli and Daman & Diu, 396210, India


fei_number: 3012160303
facility_name: VASUDHA PHARMA CHEM LIMITED
facility_name_normalized: vasudha pharma chem
city: 24 Jawaharlal Nehru Pharma City Thanam (V)
state: Parawada (M)
country: Andhra Pradesh
registrant_name: Vasudha Pharma Chem Limited
business_operations: API MANUFACTURE
business_address:
Plot No. 23,24 Jawaharlal Nehru Pharma City Thanam (V), Parawada (M), Anakapalli, Andhra Pradesh, 531019, IND


fei_number: 3038161396
facility_name: VEEDA CLINICAL RESEARCH LIMITED
facility_name_normalized: veeda clinical research
city: 2nd
state: and 3rd floor
country: 1st Main Road
registrant_name: VEEDA CLINICAL RESEARCH LIMITED
business_operations: IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING
business_qualifier: MANUFACTURES NON-GENERICS
business_address:
1st,2nd, and 3rd floor, Plot No. P-3A PID No.11-157-P-3A and P-3 PID No. 11-157-P-3, 1st Main Road, Peenya Industrial Area, 1st Stage, Bengaluru, Bengaluru, Karnataka, 560058, IND


fei_number: 3033605590
facility_name: VIRDEV INTERMEDIATES PRIVATE LIMITED
facility_name_normalized: virdev intermediates private
city: Plot No.2 Village Palsana
state: Taluka Palsana Surat 394315 Gujarat India
country: Gujarat
registrant_name: VIRDEV INTERMEDIATES PRIVATE LIMITED
business_operations: API MANUFACTURE
business_address:
Block No. 46-47, Plot No.2 Village Palsana, Taluka Palsana Surat 394315 Gujarat India, Surat, Gujarat, 394 315, IND


fei_number: 3000538143
facility_name: Valdepharm
facility_name_normalized: valdepharm
city: VAL DE REUIL CEDEX
state: NORMANDIE
country: FRA
registrant_name: Valdepharm
business_operations: API MANUFACTURE
business_address:
PARC INDUSTRIEL D INCARVILLEPARC DE LA FRINGALE - CS10606, VAL DE REUIL CEDEX, NORMANDIE, 27106, FRA


fei_number: 3013885060
facility_name: Vanamali Organics Private Limited
facility_name_normalized: vanamali organics private
city: TSIIC
state: Survey No. 480
country: Maheswaram Mandal
registrant_name: Vanamali Organics Private Limited
business_operations: API MANUFACTURE
business_address:
Plot No. 24A and 24B, TSIIC, Survey No. 480, IDA Mankhal, Maheswaram Mandal, Rangareddi, Telangana, 501359, IND


fei_number: 3009822397
facility_name: Vasudha Pharma Chem Limited
facility_name_normalized: vasudha pharma chem
city: Plot No. 79 Jawaharlal Nehru Pharma CityThanam
state: Parawada
country: Andhra Pradesh (AP)
registrant_name: Vasudha Pharma Chem Limited
business_operations: API MANUFACTURE
business_address:
Unit-II, Plot No. 79 Jawaharlal Nehru Pharma CityThanam, Parawada, Anakapalli, Andhra Pradesh (AP), 531019, IND


fei_number: 3006587427
facility_name: Vimta Labs Limited
facility_name_normalized: vimta labs
city: Life Sciences Facility
state: Neovantage Science & Technology Park Private Limited
country: Genome Valley
registrant_name: VIMTA LABS LIMITED
business_operations: API/FDF ANALYTICAL TESTING
business_address:
Plot No 5, Life Sciences Facility, Neovantage Science & Technology Park Private Limited, Shamirpet, Genome Valley, Turkapally, Medchal Malkajgiri, Hyderabad, Telangana, 500101, IND


fei_number: 3019684157
facility_name: Zhejiang Bamboo Pharmaceuticals Co.,Ltd
facility_name_normalized: zhejiang bamboo pharmaceuticals
city: Weiyi Road
state: Hangzhouwan Economic Technology Development Zone
country: Shaoxing
registrant_name: Zhejiang Bamboo Pharmaceuticals Co.,Ltd
business_operations: API MANUFACTURE
business_address:
No.9, Weiyi Road, Hangzhouwan Economic Technology Development Zone, Shangyu District, Shaoxing, Zhejiang, 312000, CHN


fei_number: 3001027745
facility_name: Zhejiang Ruibang Laboratories
facility_name_normalized: zhejiang ruibang laboratories
city: Economic and Technological Development Zone
country: Zhejiang
registrant_name: Zhejiang Ruibang Laboratories
business_operations: API MANUFACTURE
business_address:
No. 578 Binhai Tenth Road, Economic and Technological Development Zone,, Wenzhou, Zhejiang, 325025, CHN


fei_number: 3009954717
facility_name: Zhuhai Rundu Pharmaceutical Co., Ltd.
facility_name_normalized: zhuhai rundu pharmaceutical
city: North Airport Road
state: Sanzao Town
country: Zhuhai City
registrant_name: Zhuhai Rundu Pharmaceutical Co., Ltd.
business_operations: API MANUFACTURE
business_address:
No.6, North Airport Road, Sanzao Town, Jinwan District, Zhuhai City, Guangdong Province 519041, China (CHN), Zhuhai, Guangdong, 519041, CHN


fei_number: 3015849306
facility_name: Zydus Animal Health and Investments Limited
facility_name_normalized: zydus animal health and investments
city: Pharma SEZ
state: Sarkhej-Bavla
country: Village Matoda
registrant_name: Zydus Animal Health and Investments Limited
business_operations: API/FDF ANALYTICAL TESTING
business_address:
Plot No. SP 12 & 13, Pharma SEZ, Sarkhej-Bavla, N.H. No 8A, Village Matoda, Tal. Sanand, Dist.-Ahmedabad, Gujarat-382213, India., Ahmedabad, Gujarat, 382213, India


fei_number: 3006809732
facility_name: Zydus Lifesciences Limited
facility_name_normalized: zydus lifesciences
city: MIDC
state: Additional Ambernath Anandnagar
country: Thane
registrant_name: Zydus Lifesciences Limited
business_operations: API MANUFACTURE
business_address:
Plot No. N-15, MIDC, Additional Ambernath Anandnagar, Ambernath East, Thane, Maharashtra, 421506, India


# fda_recalls

recall_number: D-0710-2018
recall_initiation_date: 2018-04-17
report_date: 2018-05-09
classification: Class III
status: Terminated
recalling_firm: Rhodes Pharmaceuticals, L.P.
recalling_firm_normalized: rhodes
reason_for_recall: Failed Dissolution Specification: Low dissolution outside of specifications
code_info: Lot# AG8679B Exp. 01/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45


recall_number: D-0429-2017
recall_initiation_date: 2016-08-22
report_date: 2017-01-18
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.


recall_number: D-1172-2014
recall_initiation_date: 2014-02-13
report_date: 2014-03-26
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #70132, Exp. 09/14
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.


recall_number: D-1086-2015
recall_initiation_date: 2015-01-12
report_date: 2015-06-03
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: One lot exceeded the mechanical peel specification
code_info: Lot # 73346, Exp 03/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3


recall_number: D-1439-2016
recall_initiation_date: 2015-12-21
report_date: 2016-07-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot # 77140, Exp 05/16
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5554-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-0008-2016
recall_initiation_date: 2015-07-27
report_date: 2015-10-14
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
code_info: Lot #: 75983, Expiry: 11/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3


recall_number: D-1247-2020
recall_initiation_date: 2020-03-31
report_date: 2020-04-29
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lot: 86647 Exp. 09/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3


recall_number: D-0889-2022
recall_initiation_date: 2022-05-06
report_date: 2022-06-01
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: customer complaints exceeded respective action limits.
code_info: Lot: 90764 Exp. 08/2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide to the U.S. Market
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3


recall_number: D-1438-2016
recall_initiation_date: 2015-12-21
report_date: 2016-07-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 77303, Exp 06/16
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5553-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-1655-2012
recall_initiation_date: 2012-07-12
report_date: 2012-08-29
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #53823, Exp 08/12
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

reason_for_recall:
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-1374-2012
recall_initiation_date: 2011-07-05
report_date: 2012-06-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 43783, Exp 01/12
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA  19087; by Noven Pharmaceuticals, Inc., Miami, FL  33186.

reason_for_recall:
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-1044-2020
recall_initiation_date: 2020-03-02
report_date: 2020-03-25
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lo#t: 86081, Exp 04/2020; 86196, Exp 06/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S.A. Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3


recall_number: D-1169-2022
recall_initiation_date: 2022-06-24
report_date: 2022-07-06
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
code_info: Lot: 91272 Exp. 12/22.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3

reason_for_recall:
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.


recall_number: D-0473-2023
recall_initiation_date: 2023-03-10
report_date: 2023-03-29
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for shear.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

code_info:
Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023.


recall_number: D-1608-2014
recall_initiation_date: 2014-07-15
report_date: 2014-10-01
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot # 71165; Exp. 12/14
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.  NDC 68968-5554-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-1171-2014
recall_initiation_date: 2014-02-13
report_date: 2014-03-26
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #69618, Exp. 09/14
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.  NDC 68968-5554-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.


recall_number: D-1653-2012
recall_initiation_date: 2012-07-12
report_date: 2012-08-29
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot # 55302, Exp 12/12
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.

reason_for_recall:
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.


recall_number: D-1248-2020
recall_initiation_date: 2020-03-31
report_date: 2020-04-29
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lot: 86354 Exp. 08/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3


recall_number: D-1249-2020
recall_initiation_date: 2020-03-31
report_date: 2020-04-29
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3

code_info:
Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021


recall_number: D-1413-2012
recall_initiation_date: 2012-03-22
report_date: 2012-07-18
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot # 53995
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured  for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

reason_for_recall:
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value


recall_number: D-0296-2021
recall_initiation_date: 2021-02-19
report_date: 2021-03-10
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray,  packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.

code_info:
Lots #: 87377, Exp 3/2021, 87572, Exp 3/2021, 87581, Exp 4/2021, 87820, Exp 5/2021, 88246, Exp 6/2021, 88535, Exp 7/2021, 88536, Exp 8/2021, 88537, Exp 8/2021 & 88939, Exp 8/2021.


recall_number: D-0627-2018
recall_initiation_date: 2018-04-09
report_date: 2018-04-25
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for adhesive transfer.
code_info: Lot #: 82237 Exp. May 31, 2018
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857


recall_number: D-1171-2017
recall_initiation_date: 2017-08-30
report_date: 2017-09-27
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches  Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3

reason_for_recall:
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.


recall_number: D-0071-2023
recall_initiation_date: 2022-11-16
report_date: 2022-12-07
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
code_info: Lot: 91316 Exp. 02/2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

reason_for_recall:
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.


recall_number: D-0470-2023
recall_initiation_date: 2023-03-10
report_date: 2023-03-29
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for shear.
code_info: Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.


recall_number: D-1045-2020
recall_initiation_date: 2020-03-02
report_date: 2020-03-25
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lot#: 86083, Exp 05/2020; 86282, Exp 06/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S.A. Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3


recall_number: D-1042-2020
recall_initiation_date: 2020-03-02
report_date: 2020-03-25
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lot#: 86280, Exp 06/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S.A. Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186,  NDC 68968-5552-3


recall_number: D-1440-2016
recall_initiation_date: 2015-12-21
report_date: 2016-07-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5555-3.


recall_number: D-1372-2012
recall_initiation_date: 2011-07-05
report_date: 2012-06-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.


recall_number: D-1170-2017
recall_initiation_date: 2017-08-30
report_date: 2017-09-27
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot: 80431 Exp. 08/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches  Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3

reason_for_recall:
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.


recall_number: D-1172-2017
recall_initiation_date: 2017-08-30
report_date: 2017-09-27
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot: 80426 Exp. 10/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches  Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3

reason_for_recall:
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.


recall_number: D-1169-2017
recall_initiation_date: 2017-08-30
report_date: 2017-09-27
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot: 80433 Exp. 08/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches  Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3


recall_number: D-0393-2021
recall_initiation_date: 2021-05-20
report_date: 2021-06-02
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
code_info: Lot: 88528 Exp. 09/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

reason_for_recall:
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.


recall_number: D-1654-2012
recall_initiation_date: 2012-07-12
report_date: 2012-08-29
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot # 56506, Exp 12/12
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3.


recall_number: D-1375-2012
recall_initiation_date: 2011-07-05
report_date: 2012-06-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 41843, Exp 11/11
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA  19087; by Noven Pharmaceuticals, Inc., Miami, FL  33186.


recall_number: D-0394-2021
recall_initiation_date: 2021-05-20
report_date: 2021-06-02
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
code_info: Lot: 88530 Exp. 10/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

reason_for_recall:
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.


recall_number: D-0294-2021
recall_initiation_date: 2021-02-19
report_date: 2021-03-10
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel.
code_info: Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray,  packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.


recall_number: D-0293-2021
recall_initiation_date: 2021-02-19
report_date: 2021-03-10
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel.
code_info: Lots #: 87579, Exp 3/2021 & 88243, Exp 7/2021.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only,  Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186,  NDC 68968-5552-3.


recall_number: D-0471-2023
recall_initiation_date: 2023-03-10
report_date: 2023-03-29
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for shear.
code_info: Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3


recall_number: D-0430-2017
recall_initiation_date: 2016-08-22
report_date: 2017-01-18
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.


recall_number: D-0295-2021
recall_initiation_date: 2021-02-19
report_date: 2021-03-10
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.

code_info:
Lots #: 87580, Exp 4/2021, 87819, Exp 4/2021, 88244, Exp 6/2021, 88245, Exp 6/2021, 88532, Exp 06/2021 & 88533, Exp 7/2021.


recall_number: D-1043-2020
recall_initiation_date: 2020-03-02
report_date: 2020-03-25
classification: Class II
status: Terminated
recalling_firm: Noven Therapeutics, LLC
recalling_firm_normalized: noven therapeutics
reason_for_recall: Defective Delivery System: Out of specification for mechanical peel and shear.
code_info: Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S.A. Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3


recall_number: D-0472-2023
recall_initiation_date: 2023-03-10
report_date: 2023-03-29
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
reason_for_recall: Defective Delivery System: Out of specification for shear.
code_info: Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC  68968-5554-3.


recall_number: D-1373-2012
recall_initiation_date: 2011-07-05
report_date: 2012-06-20
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 43008, Exp 01/12; 48591, Exp 10/12
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.


recall_number: D-0428-2017
recall_initiation_date: 2016-08-22
report_date: 2017-01-18
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the US
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186,  NDC 68968-5552-3

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.


recall_number: D-312-2013
recall_initiation_date: 2013-01-31
report_date: 2013-05-08
classification: Class II
status: Terminated
recalling_firm: Noven Pharmaceuticals, Inc.
recalling_firm_normalized: noven
code_info: Lot #59824, Exp 04/13
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: methylphenidate
source: openfda
product_description:
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.

reason_for_recall:
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.


recall_number: D-385-2014
recall_initiation_date: 2013-10-07
report_date: 2014-01-01
classification: Class II
status: Terminated
recalling_firm: Amedra Pharmaceuticals LLC
recalling_firm_normalized: amedra
code_info: Lot# 243459; Exp. 01/14
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09

reason_for_recall:
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.


recall_number: D-0608-2017
recall_initiation_date: 2017-03-07
report_date: 2017-03-29
classification: Class III
status: Terminated
recalling_firm: Pfizer Inc
recalling_firm_normalized: pfizer
code_info: Lot #: 03216026A, Exp. 02/18
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within US
drug_base_substance: methylphenidate
source: openfda
product_description:
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).

reason_for_recall:
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.


recall_number: D-1164-2017
recall_initiation_date: 2017-08-04
report_date: 2017-09-27
classification: Class III
status: Terminated
recalling_firm: Pfizer Inc.
recalling_firm_normalized: pfizer
reason_for_recall: Failed Dissolution Specifications
code_info: Lot # 03216047A Exp. 02/18
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted,   Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25.


recall_number: D-1163-2017
recall_initiation_date: 2017-08-04
report_date: 2017-09-27
classification: Class III
status: Terminated
recalling_firm: Pfizer Inc.
recalling_firm_normalized: pfizer
reason_for_recall: Failed Dissolution Specifications
code_info: Lot # 03216048A, Exp. 05/18
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted,   Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.


recall_number: D-0607-2017
recall_initiation_date: 2017-03-07
report_date: 2017-03-29
classification: Class III
status: Terminated
recalling_firm: Pfizer Inc
recalling_firm_normalized: pfizer
code_info: Lot #: 03215042A, Exp. 08/17.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within US
drug_base_substance: methylphenidate
source: openfda
product_description:
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10).

reason_for_recall:
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.


recall_number: D-0609-2017
recall_initiation_date: 2017-03-07
report_date: 2017-03-29
classification: Class III
status: Terminated
recalling_firm: Pfizer Inc
recalling_firm_normalized: pfizer
code_info: Lot #: 03216025A, Exp.01/18.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within US
drug_base_substance: methylphenidate
source: openfda
product_description:
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).

reason_for_recall:
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.


recall_number: D-1227-2014
recall_initiation_date: 2014-03-03
report_date: 2014-04-16
classification: Class III
status: Terminated
recalling_firm: Novartis Pharmaceuticals Corp.
recalling_firm_normalized: novartis
code_info: Lot #: F0126
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico
drug_base_substance: methylphenidate
source: openfda
product_description:
Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05

reason_for_recall:
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets.  Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert.  The individual Medication Guides are attached to the Package Insert via a perforation.  Although t


recall_number: D-1228-2014
recall_initiation_date: 2014-03-03
report_date: 2014-04-16
classification: Class III
status: Terminated
recalling_firm: Novartis Pharmaceuticals Corp.
recalling_firm_normalized: novartis
code_info: Lot #: F0131
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico
drug_base_substance: methylphenidate
source: openfda
product_description:
Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901  Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05

reason_for_recall:
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets.  Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert.  The individual Medication Guides are attached to the Package Insert via a perforation.  Although t


recall_number: D-0006-2017
recall_initiation_date: 2016-09-02
report_date: 2016-10-12
classification: Class III
status: Terminated
recalling_firm: Shire
recalling_firm_normalized: shire
reason_for_recall: Presence of Foreign Tablets/Capsules
code_info: Lot # AF3360B; Exp. 04/19
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10


recall_number: D-0323-2024
recall_initiation_date: 2024-01-04
report_date: 2024-02-07
classification: Class I
status: Terminated
recalling_firm: Azurity Pharmaceuticals, Inc.
recalling_firm_normalized: azurity
reason_for_recall: Labeling: Label Mix-up
code_info: Lot # F230169A, Exp. 06/30/2025
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03


recall_number: D-1285-2020
recall_initiation_date: 2020-05-22
report_date: 2020-06-10
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Some bottles may contain mixed strengths of the product.
code_info: Lot #: 42614718, Exp. date 02/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the United State and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02


recall_number: D-0816-2016
recall_initiation_date: 2016-02-16
report_date: 2016-04-13
classification: Class II
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
reason_for_recall: Failed Impurities/Degradation Specifications: Out of specification for impurities.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.

code_info:
Lot #: 5245M141, Expiry: 6/16; Lot #: 0953C151, Expiry date: 8/16Lot #: 1728D151, Expiry: 9/16; Lot #: 3205G152, Expiry: 3/17.


recall_number: D-0813-2016
recall_initiation_date: 2016-02-16
report_date: 2016-04-13
classification: Class II
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
reason_for_recall: Failed Impurities/Degradation Specifications: Out of specification for impurities.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.

code_info:
Lot #: 2172#141, Expiry: 3/16; Lot #: 4217K141, Expiry: 3/16;  Lot #: 0420A151, Expiry: 7/16; Lot #: 0421A151, Expiry: 7/16; Lot #: 0854B151, Expiry: 10/16; Lot #: 1329C151, Expiry: 10/16; Lot #: 2692F151, Expiry; 2/17; Lot #: 3202G151, Expiry: 3/17; Lot #: 3796J151, Expiry: 3/17; Lot #: 3797J151, Expiry: 4/17.


recall_number: D-1488-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 152325, exp. 12/31/16, lot 154834, exp. 5/31/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95


recall_number: D-1484-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 162276, exp. 9/30/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-943-25; Blister NDC 68084-943-95


recall_number: D-1481-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 163220, exp. 10/31/17 and lot 164194, exp. 11/20/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-874-25; Blister NDC 68084-874-95


recall_number: D-1489-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 162490, exp. 9/30/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33


recall_number: D-0672-2025
recall_initiation_date: 2025-08-28
report_date: 2025-10-01
classification: Class III
status: Ongoing
recalling_firm: Granules Pharmaceuticals Inc.
recalling_firm_normalized: granules
reason_for_recall: Failed Impurities/Degradation Specifications:
code_info: Lot#: GPC250179A, Exp Date: 06-22-2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01


recall_number: D-1286-2020
recall_initiation_date: 2020-05-22
report_date: 2020-06-10
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Some bottles may contain mixed strengths of the product.
code_info: Lot #: 42617008, Exp. date 10/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the United State and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02


recall_number: D-1287-2020
recall_initiation_date: 2020-05-22
report_date: 2020-06-10
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Some bottles may contain mixed strengths of the product.
code_info: Lot #: 42617891, exp. date 01/2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the United State and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02


recall_number: D-0814-2016
recall_initiation_date: 2016-02-16
report_date: 2016-04-13
classification: Class II
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
reason_for_recall: Failed Impurities/Degradation Specifications: Out of specification for impurities.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.

code_info:
Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7/16; Lot #: 0378A151, Expiry: 7/16; Lot #: 0379A151, Expiry: 7/16; Lot #: 0697B151, Expiry: 8/16; Lot #: 2427F151, Expiry: 11/16; Lot #: 1947E151, Expiry: 11/16; Lot #: 1330C151, Expiry: 11/16; Lot #: 1331C151, Expiry: 11/16; Lot #: 1946E151, Expiry: 11/16; Lot #: 3652H151, Expiry: 2/17; Lot #: 3653H151, Expiry: 3/17, Lot #: 3654H151, Expiry: 3/17; Lot #: 4251K151, Expiry: 3/17; Lot #: 4250K151, Expiry: 4/17; Lot #: 4252K151, Expiry: 4/17; Lot #: 4249K151, Expiry: 4/17; Lot #: 5101M151, Expiry: 5/17.


recall_number: D-0566-2016
recall_initiation_date: 2015-11-12
report_date: 2016-01-20
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
code_info: Lot #: 34015516A, Exp 05/16
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.

reason_for_recall:
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.


recall_number: D-0670-2025
recall_initiation_date: 2025-08-28
report_date: 2025-10-01
classification: Class III
status: Ongoing
recalling_firm: Granules Pharmaceuticals Inc.
recalling_firm_normalized: granules
reason_for_recall: Failed Impurities/Degradation Specifications:
code_info: lot#: GPC250159A, Exp Date: 06-22-2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01


recall_number: D-1094-2014
recall_initiation_date: 2014-01-24
report_date: 2014-03-12
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
code_info: Lot # 34017575A, Exp. 10/16.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only,  Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.

reason_for_recall:
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.


recall_number: D-0815-2016
recall_initiation_date: 2016-02-16
report_date: 2016-04-13
classification: Class II
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
reason_for_recall: Failed Impurities/Degradation Specifications: Out of specification for impurities.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: US: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.

code_info:
Lot #: 1879E141, Expiry 02/16; Lot #: 1880E141, Expiry: 02/16; Lot #: 5034M142; Expiry: 5/16; Lot #: 0422A151, Expiry: 7/16; Lot #: 0423A151, Expiry: 7/16; Lot #: 1053C151, Expiry: 8/16; Lot #: 1054C151, Expiry: 8/16; Lot #: 2197E152, Expiry: 11/16; Lot #: 2198E151, Expiry: 12/16; Lot #: 2662F151, Expiry: 12/16; Lot #: 2672F152, Expiry: 3/17; Lot #: 3121G152, Expiry: 3/17; Lot #: 3798J151, Expiry: 4/17; Lot #: 5104M151, Expiry: 5/17.


recall_number: D-0047-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19T16 Exp. Jan. 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

reason_for_recall:
Labeling: Incorrect expiration date.  Product dated with 24-month expiration date instead of 18-months.


recall_number: D-0046-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10

reason_for_recall:
Labeling: Incorrect expiration date.  Product dated with 24-month expiration date instead of 18-months.


recall_number: D-1486-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95

code_info:
Lot 152254, exp. 12/31/16, lot 152324, exp. 3/31/17, lot 154833, exp. 5/31/17, lot 162406, exp. 12/31/17


recall_number: D-0048-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10

reason_for_recall:
Labeling: Incorrect expiration date.  Product dated with 24-month expiration date instead of 18-months.


recall_number: D-0045-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10


recall_number: D-1539-2022
recall_initiation_date: 2022-08-29
report_date: 2022-09-21
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA Inc
recalling_firm_normalized: teva
code_info: Lot #: 100023340, Exp 10/2024
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the US.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.

reason_for_recall:
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.


recall_number: D-1490-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 152418, exp. 12/31/16, lot 153544, exp. 3/31/17, lot 154835, exp. 5/31/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33


recall_number: D-0669-2025
recall_initiation_date: 2025-08-28
report_date: 2025-10-01
classification: Class III
status: Ongoing
recalling_firm: Granules Pharmaceuticals Inc.
recalling_firm_normalized: granules
reason_for_recall: Failed Impurities/Degradation Specifications:
code_info: Lot#: GPC250158A, Exp Date: 06-22-2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01


recall_number: D-0671-2025
recall_initiation_date: 2025-08-28
report_date: 2025-10-01
classification: Class III
status: Ongoing
recalling_firm: Granules Pharmaceuticals Inc.
recalling_firm_normalized: granules
reason_for_recall: Failed Impurities/Degradation Specifications:
code_info: Lot#: GPC250178A, Exp Date: 06-22-2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01


recall_number: D-1487-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 162489, exp. 9/30/17 and lot 162910, exp. 10/31/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33


recall_number: D-0043-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19S07 Exp. Sept. 2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10


recall_number: D-0143-2020
recall_initiation_date: 2019-09-19
report_date: 2019-10-23
classification: Class II
status: Terminated
recalling_firm: Aurobindo Pharma USA Inc.
recalling_firm_normalized: aurobindo
code_info: Batch 07319032A1, Exp 02/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the US
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01

reason_for_recall:
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.


recall_number: D-1283-2015
recall_initiation_date: 2015-06-24
report_date: 2015-08-12
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Failed Impurities/Degradation Specifications: out of specification for unknown impurity
code_info: Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg   (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02


recall_number: D-1483-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 150950, exp. 3/31/17 and lot 154813, exp. 5/31/2017
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 60687-133-25; Blister NDC 60687-133-95


recall_number: D-0050-2015
recall_initiation_date: 2014-10-08
report_date: 2014-11-05
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
code_info: Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S. Nationwide including Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA  18960, NDC: 0555-0972-02.   0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.


recall_number: D-190-2013
recall_initiation_date: 2013-02-13
report_date: 2013-03-13
classification: Class III
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
code_info: Lot #: 50077231
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.

reason_for_recall:
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications.  All other test specifications were met.


recall_number: D-0044-2021
recall_initiation_date: 2020-10-09
report_date: 2020-10-28
classification: Class III
status: Terminated
recalling_firm: ANI Pharmaceuticals, Inc.
recalling_firm_normalized: ani
code_info: Lot: 19S10 Exp. Sept. 2021, 19S11 Exp. Oct. 2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10


recall_number: D-1485-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 162278, exp. 10/31/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 60687-154-25; Blister NDC 60687-154-95


recall_number: D-0673-2025
recall_initiation_date: 2025-08-28
report_date: 2025-10-01
classification: Class III
status: Ongoing
recalling_firm: Granules Pharmaceuticals Inc.
recalling_firm_normalized: granules
reason_for_recall: Failed Impurities/Degradation Specifications:
code_info: Lot#: GPC250181A, Exp Date: 06-19-2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01


recall_number: D-0642-2025
recall_initiation_date: 2025-08-19
report_date: 2025-09-17
classification: Class II
status: Ongoing
recalling_firm: Lannett Company Inc.
recalling_firm_normalized: lannett company
code_info: Lot#: 25283185A. Expiry: 02/28/2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: OH
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.

reason_for_recall:
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.


recall_number: D-1482-2016
recall_initiation_date: 2016-08-24
report_date: 2016-09-14
classification: Class II
status: Terminated
recalling_firm: Amerisource Health Services
recalling_firm_normalized: amerisource health services
reason_for_recall: Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
code_info: Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Product was distributed in the following states: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 68084-936-25; Blister NDC 68084-936-95


recall_number: D-0236-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

code_info:
Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.


recall_number: D-0235-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
code_info: Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.


recall_number: D-0239-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

code_info:
Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.


recall_number: D-765-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-29
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: atomoxetine
source: openfda
reason_for_recall:
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014;  ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014;  OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014;  OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree:  AD73

code_info:
ATOMOXETINE HCL, Capsule, 40 mg has the following codes:    Pedigree: AD21790_82, EXP: 5/1/2014;   Pedigree: AD46265_52, EXP: 5/15/2014;  Pedigree: AD60272_89, EXP: 5/22/2014;  Pedigree: AD73525_67, EXP: 5/30/2014;  Pedigree: W003014, EXP: 6/11/2014.


recall_number: D-0244-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

code_info:
Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.


recall_number: D-527-2015
recall_initiation_date: 2014-11-14
report_date: 2015-04-29
classification: Class II
status: Terminated
recalling_firm: Attix Pharmaceuticals
recalling_firm_normalized: attix
code_info: All lots repackaged and distributed between 01/05/12 to 02/12/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide to compounding pharmacies and research organizations.
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

reason_for_recall:
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.


recall_number: D-0231-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

code_info:
Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.


recall_number: D-767-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-29
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
code_info: ATOMOXETINE HCL, Capsule, 18 mg has the following codes: Pedigree: AD30140_16, EXP: 5/7/2014.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: atomoxetine
source: openfda
reason_for_recall:
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug:    LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.


recall_number: D-0240-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

code_info:
Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.


recall_number: D-0232-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

code_info:
Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.


recall_number: D-0243-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

code_info:
Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.


recall_number: D-0233-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

code_info:
Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.


recall_number: D-768-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-29
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: atomoxetine
source: openfda
reason_for_recall:
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs:   ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014;  PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014;  RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014;  PRO

code_info:
ATOMOXETINE HCL, Capsule, 80 mg has the following codes:   Pedigree: AD30140_19, EXP: 5/7/2014;  Pedigree: W003685, EXP: 6/25/2014;  Pedigree: AD60272_49, EXP: 5/22/2014;  Pedigree: W003003, EXP: 6/11/2014.


recall_number: D-0237-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
code_info: Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.


recall_number: D-0242-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
code_info: Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.


recall_number: D-0234-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

code_info:
Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.


recall_number: D-0238-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

code_info:
Lot Numbers:  19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.


recall_number: D-0241-2025
recall_initiation_date: 2025-01-29
report_date: 2025-02-26
classification: Class II
status: Ongoing
recalling_firm: Glenmark Pharmaceuticals Inc., USA
recalling_firm_normalized: glenmark pharmaceuticals inc.,
reason_for_recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the U.S
drug_base_substance: atomoxetine
source: openfda
product_description:
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

code_info:
Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.


recall_number: D-1091-2022
recall_initiation_date: 2022-04-13
report_date: 2022-06-15
classification: Class II
status: Terminated
recalling_firm: Mckesson Medical-Surgical Inc. Corporate Office
recalling_firm_normalized: mckesson medical-surgical inc. corporate office
reason_for_recall: cGMP deviations: Temperature abuse
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA nationwide.
drug_base_substance: clonidine
source: openfda
product_description:
Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

code_info:
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.


recall_number: D-1682-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03202015@58, 6/18/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

reason_for_recall:
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility


recall_number: D-1702-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03202015@84, 6/18/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

reason_for_recall:
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility


recall_number: D-1701-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

reason_for_recall:
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

code_info:
All lots distributed between November 2014 and May 2015;  03092015@14, 6/7/2015; 04242015@54, 7/23/2015


recall_number: D-1610-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03222015@23, 5/31/2015; 04072015@68, 7/6/2015; 04142015@76, 7/13/2015


recall_number: D-0709-2021
recall_initiation_date: 2020-10-05
report_date: 2021-08-18
classification: Class I
status: Terminated
recalling_firm: Med Shop Total Care Inc.
recalling_firm_normalized: med shop total care
reason_for_recall: Non-Sterility
code_info: Lot #: a) 09302020@30, BUD 10/23/2020, b) 10022020@14, BUD 10/30/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Texas and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths:  a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only,   Med Shop Total Care 470 East Loop 281 Longview, TX 75605


recall_number: D-0051-2021
recall_initiation_date: 2020-10-05
report_date: 2020-11-04
classification: Class II
status: Terminated
recalling_firm: Boehringer Ingelheim Pharmaceuticals, Inc.
recalling_firm_normalized: boehringer ingelheim
reason_for_recall: An extraneous peak was observed for dissolution testing.
code_info: Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
Catapres (clonidine hydrochloride, USP)  0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01


recall_number: D-1491-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03022015@3, 5/31/2015; 03202015@54, 6/18/2015; 04172015@34, 6/16/2015


recall_number: D-1444-2014
recall_initiation_date: 2014-07-17
report_date: 2014-07-30
classification: Class III
status: Terminated
recalling_firm: X-Gen Pharmaceuticals Inc.
recalling_firm_normalized: x-gen
code_info: Lot: PLNB1412, Exp 12/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY  14814, NDC 39822-2000-1.

reason_for_recall:
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".


recall_number: D-1706-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  02252015@12, 5/20/2015; 03242015@80, 6/22/2015; 04222015@24, 7/21/2015


recall_number: D-0590-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

reason_for_recall:
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

code_info:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.


recall_number: D-1278-2022
recall_initiation_date: 2022-06-30
report_date: 2022-07-27
classification: Class II
status: Terminated
recalling_firm: Nephron Sterile Compounding Center LLC
recalling_firm_normalized: nephron sterile compounding center
reason_for_recall: Lack of Assurance of Sterility
code_info: Lots: RP2003A, Exp. 7/20/2022; RP2003B, Exp. 7/20/2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: clonidine
source: openfda
product_description:
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50


recall_number: D-1542-2012
recall_initiation_date: 2012-05-25
report_date: 2012-08-22
classification: Class II
status: Terminated
recalling_firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
recalling_firm_normalized: franck's lab inc., d.b.a. franck's compounding lab
code_info: Rx #'s:N0395798 N0397394 N0392201 N0400799 N0403781 N0407180 N0390189
voluntary_mandated: Voluntary: Firm initiated
drug_base_substance: clonidine
source: openfda
product_description:
HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)

reason_for_recall:
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

distribution_pattern:
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies


recall_number: D-0584-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

reason_for_recall:
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

code_info:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.


recall_number: D-1282-2015
recall_initiation_date: 2015-07-09
report_date: 2015-08-05
classification: Class II
status: Terminated
recalling_firm: Mutual Pharmaceutical Company, Inc.
recalling_firm_normalized: mutual pharmaceutical company,
code_info: Lot #: 6676701 and 6676801, exp 1/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nartionwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

reason_for_recall:
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer


recall_number: D-0023-2015
recall_initiation_date: 2014-07-09
report_date: 2014-10-22
classification: Class II
status: Terminated
recalling_firm: Gyma Laboratories Of Amer,Inc
recalling_firm_normalized: gyma laboratories of amer,inc
code_info: Lot Numbers: 166247, 166248, Exp 10/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

reason_for_recall:
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.


recall_number: D-1152-2022
recall_initiation_date: 2022-06-09
report_date: 2022-06-29
classification: Class II
status: Terminated
recalling_firm: Mayne Pharma Inc
recalling_firm_normalized: mayne
code_info: Lot: 41179A Exp. Jan 2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the US Market
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton  (51862-455-04), Rx only,  Manufactured for: Mayne Pharma Greenville, NC 27834

reason_for_recall:
Defective Delivery System:  Out of specification for release liner removal force results at the 3-month CRT stability timepoint.


recall_number: D-1291-2020
recall_initiation_date: 2020-05-26
report_date: 2020-06-17
classification: Class III
status: Terminated
recalling_firm: UNICHEM PHARMACEUTICALS USA INC
recalling_firm_normalized: unichem
code_info: Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the United States
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01

reason_for_recall:
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.


recall_number: D-1595-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03092015@20, 6/7/2015; 03202015@72, 6/18/2015; 04132015@9, 6/12/2015


recall_number: D-0829-2020
recall_initiation_date: 2020-01-29
report_date: 2020-02-12
classification: Class III
status: Terminated
recalling_firm: UNICHEM PHARMACEUTICALS USA INC
recalling_firm_normalized: unichem
code_info: Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the US
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816.  NDC 29300-135-01

reason_for_recall:
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.


recall_number: D-0480-2018
recall_initiation_date: 2018-02-09
report_date: 2018-02-28
classification: Class II
status: Terminated
recalling_firm: American Pharmaceutical Ingredients LLC
recalling_firm_normalized: american pharmaceutical ingredients
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within USA.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

reason_for_recall:
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

code_info:
Lot #: a) 070915-1, Exp. 12/31/2019; b) 070915-1, Exp. 12/31/2019; c) 070915-1, Exp. 12/31/2019; d) 070915-1, Exp. 12/31/2019


recall_number: D-0606-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

reason_for_recall:
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

code_info:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.


recall_number: D-0052-2021
recall_initiation_date: 2020-10-05
report_date: 2020-11-04
classification: Class II
status: Terminated
recalling_firm: Boehringer Ingelheim Pharmaceuticals, Inc.
recalling_firm_normalized: boehringer ingelheim
reason_for_recall: An extraneous peak was observed for dissolution testing.
code_info: Lot # 861135, C34139, EXP Nov 2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
Catapres (clonidine hydrochloride, USP)  0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01


recall_number: D-1280-2015
recall_initiation_date: 2015-07-09
report_date: 2015-08-05
classification: Class II
status: Terminated
recalling_firm: Mutual Pharmaceutical Company, Inc.
recalling_firm_normalized: mutual pharmaceutical company,
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nartionwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA

reason_for_recall:
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

code_info:
Lot #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17


recall_number: D-0608-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0578-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1471-2012
recall_initiation_date: 2012-05-25
report_date: 2012-08-22
classification: Class II
status: Terminated
recalling_firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
recalling_firm_normalized: franck's lab inc., d.b.a. franck's compounding lab
code_info: Rx #'s:N0388659 N0392060 N0406634 N0406913 N0397272
voluntary_mandated: Voluntary: Firm initiated
drug_base_substance: clonidine
source: openfda
product_description:
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS)

reason_for_recall:
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

distribution_pattern:
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies


recall_number: D-0601-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0603-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0604-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1729-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;    04092015@82, 6/8/2015; 05082015@37, 7/7/2015


recall_number: D-1615-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  02232015@22, 5/24/2015; 03202015@81, 6/18/2015


recall_number: D-1712-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03122015@23, 6/10/2015; 04092015@73, 6/8/2015; 05082015@39, 7/7/2015


recall_number: D-0570-2016
recall_initiation_date: 2015-12-24
report_date: 2016-01-27
classification: Class II
status: Terminated
recalling_firm: Amerita Specialty Infusion Services
recalling_firm_normalized: amerita specialty infusion services
reason_for_recall: Lack of Assurance of Sterility
code_info: Lot # 112621/E; Exp. 10/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: AZ only. No foreign distribution.
drug_base_substance: clonidine
source: openfda
product_description:
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614


recall_number: D-1713-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03162015@69, 6/14/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-1708-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03162015@70, 6/14/2015; 04142015@72, 5/20/2015


recall_number: D-0595-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0128-2019
recall_initiation_date: 2018-10-22
report_date: 2018-11-07
classification: Class II
status: Terminated
recalling_firm: Boehringer Ingelheim Pharmaceuticals, Inc.
recalling_firm_normalized: boehringer ingelheim
reason_for_recall: Failed Dissolution Specifications: OOS resultsduring routine stability testing
code_info: Lot: 757739, EXP 9/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed nationwide in the USA and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01


recall_number: D-0559-2016
recall_initiation_date: 2015-07-10
report_date: 2016-01-06
classification: Class II
status: Terminated
recalling_firm: PD-Rx Pharmaceuticals, Inc.
recalling_firm_normalized: pd-rx
reason_for_recall: cGMP Deviations
code_info: Lot# B14D26, Exp 02/16
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Alabama
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01


recall_number: D-1680-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03122015@19, 6/10/2015; 04242015@48, 7/23/2015


recall_number: D-1335-2020
recall_initiation_date: 2020-04-23
report_date: 2020-07-01
classification: Class III
status: Terminated
recalling_firm: QuVa Pharma, Inc.
recalling_firm_normalized: quva
reason_for_recall: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the US.
drug_base_substance: clonidine
source: openfda
product_description:
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804,  NDC 70092143350

code_info:
Lots: 30008721, Exp. 4/26/2020; 30008198, 30008554, Exp. 4/29/2020; 30008861, Exp. 4/30/2020; 30008859, Exp. 5/5/2020;  30008949, Exp. 5/10/2020; 30009073, Exp. 5/14/2020; 30009074, Exp. 30009138, Exp. 5/17/2020; 30009139, 30009227, Exp. 5/19/2020; 30009228, Exp. 5/20/2020; 30009387, 30009388, Exp. 5/27/2020; 30009410, 30009411, Exp. 5/28/2020; 30009413, Exp. 5/31/2020; 30009412,  30009489, Exp. 6/1/2020; 30009539, 30009563, Exp. 6/3/2020


recall_number: D-1490-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03162015@71, 5/20/2015; 04272015@31, 7/26/2015


recall_number: D-0583-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
code_info: All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1602-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  05042015@3, 8/2/2015; 03122015@101, 5/20/2015


recall_number: D-0602-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0598-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363


recall_number: D-1609-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;    02272015@33, 5/28/2015; 04012015@3, 6/30/2015


recall_number: D-1589-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03022015@81, 5/31/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0088-2015
recall_initiation_date: 2014-08-27
report_date: 2014-11-05
classification: Class II
status: Terminated
recalling_firm: Martin Avenue Pharmacy, Inc.
recalling_firm_normalized: martin avenue pharmacy
code_info: Lot Number: 08112014@55, Exp 9/10/2014
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes,  Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

reason_for_recall:
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.


recall_number: D-0605-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1670-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03162015@8, 6/14/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0235-2022
recall_initiation_date: 2021-10-28
report_date: 2021-11-24
classification: Class III
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Failed Impurities/Degradation Specifications
code_info: Lot# 1369117B, exp. date 11/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04


recall_number: D-0600-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363


recall_number: D-0580-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1672-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03242015@81, 6/22/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-1498-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 04172015@36m, 6/16/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0755-2016
recall_initiation_date: 2016-02-04
report_date: 2016-03-16
classification: Class II
status: Terminated
recalling_firm: Hartley Medical Center Pharmacy, Incorporated
recalling_firm_normalized: hartley medical center pharmacy, incorporated
reason_for_recall: Lack of Assurance of Sterility
code_info: BUD: 5/3/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide. No foreign distribution.
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/  Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA


recall_number: D-1678-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03092015@17, 6/7/2015, 04032015@26, 7/2/2015; 5012015@15, 7/30/2015


recall_number: D-1590-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03092015@11, 6/7/2015; 03302015@7, 6/28/2015; 4242015@50, 7/23/2015


recall_number: D-1281-2015
recall_initiation_date: 2015-07-09
report_date: 2015-08-05
classification: Class II
status: Terminated
recalling_firm: Mutual Pharmaceutical Company, Inc.
recalling_firm_normalized: mutual pharmaceutical company,
code_info: Lot #: a) 6643901, exp 5/16, 6677201, exp 1/17; b) 6677101, EXP 1/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nartionwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.

reason_for_recall:
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer


recall_number: D-0607-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging,  AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1677-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03202015@61, 6/18/2015; 04172015@38, 6/16/2015


recall_number: D-1669-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015  04142015@68, 7/13/2015; 03162015@67, 5/20/2015


recall_number: D-1483-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  04062015@12, 7/5/2015; 04062015@35, 7/5/2015; 05012015@50, 7/30/2015


recall_number: D-1084-2019
recall_initiation_date: 2019-03-29
report_date: 2019-04-17
classification: Class III
status: Terminated
recalling_firm: X-Gen Pharmaceuticals Inc.
recalling_firm_normalized: x-gen
code_info: Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.

reason_for_recall:
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.


recall_number: D-1482-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03092015@16, 6/7/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-1704-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 04012015@6, 6/30/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0024-2015
recall_initiation_date: 2014-07-09
report_date: 2014-10-22
classification: Class II
status: Terminated
recalling_firm: Gyma Laboratories Of Amer,Inc
recalling_firm_normalized: gyma laboratories of amer,inc
code_info: Lot Numbers: 167219, 163367, 167220, 167221, Exp 03/2017
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

reason_for_recall:
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.


recall_number: D-596-2015
recall_initiation_date: 2014-11-14
report_date: 2015-04-29
classification: Class II
status: Terminated
recalling_firm: Attix Pharmaceuticals
recalling_firm_normalized: attix
code_info: All lots repackaged and distributed between 01/05/12 to 02/12/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide to compounding pharmacies and research organizations.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

reason_for_recall:
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.


recall_number: D-1681-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03122015@24, 6/10/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0761-2016
recall_initiation_date: 2016-02-04
report_date: 2016-03-16
classification: Class II
status: Terminated
recalling_firm: Hartley Medical Center Pharmacy, Incorporated
recalling_firm_normalized: hartley medical center pharmacy, incorporated
reason_for_recall: Lack of Assurance of Sterility
code_info: BUD: 5/3/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide. No foreign distribution.
drug_base_substance: clonidine
source: openfda
product_description:
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA


recall_number: D-0596-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0113-2026
recall_initiation_date: 2025-10-10
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: QuVa Pharma, Inc.
recalling_firm_normalized: quva
reason_for_recall: Presence of Particulate Matter
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S. Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use.  THIS IS A COMPOUNDED DRUG.  QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478.   NDC 70092-1433-50

code_info:
Lot, expiry: 10149179 , exp 10/15/2025 ;  10149503 , exp 10/13/2025 ;  10149504 , exp 10/13/2025 ;  10149657 , exp 10/16/2025 ;  10149658 , exp 10/16/2025 ;  10149659 , exp 10/15/2025 ;  10150137 , exp 10/23/2025 ;  10150138 , exp 10/23/2025 ;  10150139 , exp 10/23/2025 ;  10150140 , exp 10/23/2025 ;  10149729 , exp 10/16/2025 ;  10149730 , exp 10/16/2025 ;  10149732 , exp 10/16/2025 ;  10149733 , exp 10/16/2025 ;  10149737 , exp 10/16/2025 ;  10149738 , exp 10/16/2025 ;  10149790 , exp 10/17/2025 ;  10149787 , exp 10/16/2025 ;  10149788 , exp 10/16/2025 ;  10149791 , exp 10/17/2025 ;  10149792 , exp 10/16/2025 ;  10149800 , exp 10/16/2025 ;  10149841 , exp 10/19/2025 ;  10149833 , exp 10/19/2025 ;  10149840 , exp 10/19/2025 ;  10149842 , exp 10/20/2025 ;  10149838 , exp 10/19/2025 ;  10149839 , exp 10/19/2025 ;  10149843 , exp 10/20/2025 ;  10149968 , exp 10/20/2025 ;  10149969 , exp 10/21/2025 ;  10150007 , exp 10/22/2025 ;  10150134 , exp 10/23/2025 ;  10150253 , exp 10/26/2025 ;  10150254 , exp 10/26/2025 ;  10150135 , exp 10/23/2025 ;  10150302 , exp 10/27/2025 ;  10150303 , exp 10/28/2025 ;  10150182 , exp 10/31/2025 ;  10150183 , exp 10/23/2025 ;  10150185 , exp 10/24/2025 ;  10150184 , exp 10/23/2025 ;  10150186 , exp 10/23/2025 ;  10150187 , exp 10/23/2025 ;  10150204 , exp 10/27/2025 ;  10150357 , exp 10/29/2025 ;  10150358 , exp 10/29/2025 ;  10150361 , exp 10/29/2025 ;  10150362 , exp 10/29/2025 ;  10150525 , exp 10/30/2025 ;  10150526 , exp 10/30/2025 ;  10150527 , exp 10/30/2025 ;  10150528 , exp 10/30/2025 ;  10150532 , exp 10/30/2025 ;  10150533 , exp 10/30/2025 ;  10150534 , exp 10/30/2025 ;  10150535 , exp 10/30/2025 ;  10150537 , exp 10/30/2025 ;  10150538 , exp 10/30/2025 ;  10150550 , exp 10/31/2025 ;  10150551 , exp 10/31/2025 ;  10150596 , exp 11/3/2025 ;  10150597 , exp 11/3/2025 ;  10150598 , exp 11/3/2025 ;  10150599 , exp 11/3/2025 ;  10150616 , exp 11/3/2025 ;  10150617 , exp 11/3/2025 ;  10150619 , exp 11/3/2025 ;  10150620 , exp 11/3/2025 ;  10150631 , exp 11/3/2025 ;  10150632 , exp 11/3/2025 ;  10150633 , exp 11/3/2025 ;  10150634 , exp 11/3/2025 ;  10150613 , exp 11/3/2025 ;  10150614 , exp 11/3/2025 ;  10150677 , exp 11/3/2025 ;  10150720 , exp 11/4/2025 ;  10150650 , exp 11/5/2025 ;  10150778 , exp 11/5/2025 ;  10150779 , exp 11/5/2025 ;  10150883 , exp 11/5/2025 ;  10151024 , exp 11/5/2025 ;  10151025 , exp 11/5/2025 ;  10150884 , exp 11/6/2025 ;  10151061 , exp 11/11/2025 ;  10151069 , exp 11/11/2025 ;  10150944 , exp 11/9/2025 ;  10150945 , exp 11/9/2025 ;  10151121 , exp 11/12/2025 ;  10151129 , exp 11/13/2025 ;  10150948 , exp 11/9/2025 ;  10150949 , exp 11/9/2025 ;  10151184 , exp 11/13/2025 ;  10151195 , exp 11/13/2025 ;  10150961 , exp 11/9/2025 ;  10150980 , exp 11/10/2025 ;  10150981 , exp 11/10/2025 ;  10150984 , exp 11/10/2025 ;  10150985 , exp 11/10/2025 ;  10151013 , exp 11/10/2025 ;  10151051 , exp 11/11/2025 ;  10151052 , exp 11/11/2025 ;  10151055 , exp 11/11/2025 ;  10151056 , exp 11/11/2025 ;  10151070 , exp 11/12/2025 ;  10151071 , exp 11/11/2025 ;  10151014 , exp 11/11/2025 ;  10151072 , exp 11/12/2025 ;  10151074 , exp 11/12/2025 ;  10151075 , exp 11/12/2025 ;  10151078 , exp 11/12/2025 ;  10151079 , exp 11/12/2025 ;  10151111 , exp 11/12/2025 ;  10151112 , exp 11/12/2025 ;  10151115 , exp 11/12/2025 ;  10151116 , exp 11/12/2025 ;  10151130 , exp 11/12/2025 ;  10151131 , exp 11/13/2025 ;  10151132 , exp 11/13/2025 ;  10151134 , exp 11/13/2025 ;  10151135 , exp 11/13/2025 ;  10151138 , exp 11/13/2025 ;  10151139 , exp 11/13/2025 ;  10151173 , exp 11/17/2025 ;  10151174 , exp 11/17/2025 ;  10151177 , exp 11/13/2025 ;  10151178 , exp 11/13/2025 ;  10151196 , exp 11/14/2025 ;  10151197 , exp 11/13/2025 ;  10151199 , exp 11/14/2025 ;  10151200 , exp 11/14/2025 ;  10151203 , exp 11/14/2025 ;  10151204 , exp 11/14/2025 ;  10151418 , exp 11/19/2025 ;  10151419 , exp 11/19/2025 ;  10151423 , exp 11/19/2025 ;  10151424 , exp 11/19/2025 ;  10151442 , exp 11/19/2025 ;  10151443 , exp 11/19/2025 ;  10151447 , exp 11/19/2025 ;  10151448 , exp 11/19/2025 ;  10151462 , exp 11/19/2025 ;  10151463 , exp 11/19/2025 ;  10151464 , exp 11/19/2025 ;  10151466 , exp 11/20/2025 ;  10151468 , exp 11/19/2025 ;  10151467 , exp 11/20/2025 ;  10151470 , exp 11/24/2025 ;  10151471 , exp 11/24/2025 ;  10151475 , exp 11/24/2025 ;  10151476 , exp 11/24/2025 ;  10151505 , exp 11/23/2025 ;  10151506 , exp 11/23/2025 ;  10151509 , exp 11/23/2025 ;  10151510 , exp 11/23/2025 ;  10151523 , exp 11/24/2025 ;  10151524 , exp 11/24/2025 ;  10151525 , exp 11/23/2025 ;  10151527 , exp 11/24/2025 ;  10151528 , exp 11/24/2025 ;  10151531 , exp 11/24/2025 ;  10151532 , exp 11/24/2025 ;  10151546 , exp 11/24/2025 ;  10151547 , exp 11/24/2025 ;  10151550 , exp 11/24/2025 ;  10151551 , exp 11/24/2025 ;  10151563 , exp 11/24/2025 ;  10151564 , exp 11/24/2025 ;  10151567 , exp 11/24/2025 ;  10151568 , exp 11/24/2025 ;  10151580 , exp 11/24/2025 ;  10151581 , exp 11/24/2025 ;  10151582 , exp 11/24/2025 ;  10151584 , exp 11/25/2025 ;  10151585 , exp 11/25/2025 ;  10151588 , exp 11/25/2025 ;  10151589 , exp 11/25/2025 ;  10151600 , exp 11/25/2025 ;  10151601 , exp 11/25/2025 ;  10151604 , exp 11/25/2025 ;  10151605 , exp 11/25/2025 ;  10151705 , exp 11/25/2025 ;  10151706 , exp 11/25/2025 ;  10151707 , exp 11/25/2025 ;  10151711 , exp 11/26/2025 ;  10151727 , exp 11/26/2025 ;  10151728 , exp 11/25/2025 ;  10151729 , exp 11/25/2025 ;  10151770 , exp 11/26/2025 ;  10151771 , exp 11/27/2025 ;  10151788 , exp 11/26/2025 ;  10151789 , exp 11/26/2025 ;  10151969 , exp 12/2/2025 ;  10151979 , exp 12/1/2025 ;  10151980 , exp 12/1/2025 ;  10151970 , exp 12/2/2025 ;  10151981 , exp 12/2/2025 ;  10151982 , exp 12/1/2025 ;  10151971 , exp 12/2/2025 ;  10152008 , exp 12/2/2025 ;  10152009 , exp 12/2/2025 ;  10152010 , exp 12/3/2025 ;  10152060 , exp 12/3/2025 ;  10152061 , exp 12/9/2025 ;  10152011 , exp 12/2/2025 ;  10152121 , exp 12/4/2025 ;  10152122 , exp 12/4/2025 ;  10152012 , exp 12/3/2025 ;  10152064 , exp 12/4/2025 ;  10152123 , exp 12/4/2025 ;  10152124 , exp 12/5/2025 ;  10152178 , exp 12/7/2025 ;  10152062 , exp 12/4/2025 ;  10152175 , exp 12/7/2025 ;  10152179 , exp 12/8/2025 ;  10152180 , exp 12/8/2025 ;  10152063 , exp 12/4/2025 ;  10152176 , exp 12/7/2025 ;  10152177 , exp 12/7/2025 ;  10152323 , exp 12/9/2025 ;  10152339 , exp 12/9/2025 ;  10152374 , exp 12/11/2025 ;  10152340 , exp 12/10/2025 ;  10152341 , exp 12/10/2025 ;  10152375 , exp 12/11/2025 ;  10152371 , exp 12/10/2025 ;  10152372 , exp 12/10/2025 ;  10152376 , exp 12/11/2025 ;  10152373 , exp 12/10/2025 ;  10152393 , exp 12/11/2025 ;  10152428 , exp 12/11/2025 ;  10152394 , exp 12/11/2025 ;  10152395 , exp 12/10/2025 ;  10152429 , exp 12/12/2025 ;  10152774 , exp 12/16/2025 ;  10152775 , exp 12/16/2025 ;  10152834 , exp 12/21/2025 ;  10152835 , exp 12/21/2025 ;  10152861 , exp 12/22/2025 ;


recall_number: D-0591-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-0599-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1679-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03022015@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 6/16/2015


recall_number: D-0053-2021
recall_initiation_date: 2020-10-05
report_date: 2020-11-04
classification: Class II
status: Terminated
recalling_firm: Boehringer Ingelheim Pharmaceuticals, Inc.
recalling_firm_normalized: boehringer ingelheim
reason_for_recall: An extraneous peak was observed for dissolution testing.
code_info: Lot # 954953, EXP Jan 2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA and Puerto Rico
drug_base_substance: clonidine
source: openfda
product_description:
Catapres (clonidine hydrochloride, USP)  0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01


recall_number: D-1541-2022
recall_initiation_date: 2022-09-19
report_date: 2022-09-28
classification: Class III
status: Terminated
recalling_firm: UNICHEM PHARMACEUTICALS USA INC
recalling_firm_normalized: unichem
code_info: Lot # GCLH22005, exp. date 02/29/2024
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Distributed Nationwide in the USA
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01

reason_for_recall:
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,


recall_number: D-1730-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 04242015@52, 7/23/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-1486-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  02252015@51, 5/20/2015; 04222015@22, 7/21/2015


recall_number: D-1481-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
code_info: All lots distributed between November 2014 and May 2015; 03092015@27, 5/20/2015
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN


recall_number: D-0765-2016
recall_initiation_date: 2016-02-04
report_date: 2016-03-16
classification: Class II
status: Terminated
recalling_firm: Hartley Medical Center Pharmacy, Incorporated
recalling_firm_normalized: hartley medical center pharmacy, incorporated
reason_for_recall: Lack of Assurance of Sterility
code_info: BUD: 5/3/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide. No foreign distribution.
drug_base_substance: clonidine
source: openfda
product_description:
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA


recall_number: D-1460-2012
recall_initiation_date: 2012-05-25
report_date: 2012-08-22
classification: Class II
status: Terminated
recalling_firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
recalling_firm_normalized: franck's lab inc., d.b.a. franck's compounding lab
voluntary_mandated: Voluntary: Firm initiated
drug_base_substance: clonidine
source: openfda
product_description:
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)

code_info:
Rx #'s:N0406290, N0387600, N0390988, N0393344, N0396645, N0400013, N0403729, N0406665, N0410203, N0393490


recall_number: D-115-2013
recall_initiation_date: 2012-09-26
report_date: 2013-01-09
classification: Class II
status: Terminated
recalling_firm: New England Compounding Center
recalling_firm_normalized: new england compounding center
reason_for_recall: Lack of Assurance of Sterility
code_info: All lot codes
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA


recall_number: D-1705-2015
recall_initiation_date: 2015-06-02
report_date: 2015-09-23
classification: Class II
status: Terminated
recalling_firm: The Compounding Pharmacy of America
recalling_firm_normalized: the compounding pharmacy of america
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: clonidine
source: openfda
product_description:
Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

code_info:
All lots distributed between November 2014 and May 2015;  03092015@25, 6/7/2015; 04242015@44, 7/23/2015


recall_number: D-1066-2022
recall_initiation_date: 2022-04-13
report_date: 2022-06-15
classification: Class II
status: Terminated
recalling_firm: Mckesson Medical-Surgical Inc. Corporate Office
recalling_firm_normalized: mckesson medical-surgical inc. corporate office
reason_for_recall: cGMP deviations: Temperature abuse
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA nationwide.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10

code_info:
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.


recall_number: D-0597-2020
recall_initiation_date: 2019-09-03
report_date: 2019-12-18
classification: Class II
status: Terminated
recalling_firm: Coast Quality Pharmacy, LLC dba Anazao Health
recalling_firm_normalized: coast quality pharmacy, llc dba anazao health
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: clonidine
source: openfda
product_description:
Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.


recall_number: D-1430-2015
recall_initiation_date: 2015-07-28
report_date: 2015-09-23
classification: Class III
status: Terminated
recalling_firm: Novartis Pharmaceuticals Corp.
recalling_firm_normalized: novartis
code_info: Lot #: F0002, Exp 12/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: NJ - site for distributor
drug_base_substance: dexmethylphenidate
source: openfda
product_description:
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules.  Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

reason_for_recall:
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.


recall_number: D-1448-2016
recall_initiation_date: 2016-07-11
report_date: 2016-08-03
classification: Class II
status: Terminated
recalling_firm: Actavis Inc
recalling_firm_normalized: actavis
reason_for_recall: Failed Dissolution Specifications
code_info: Lot #: 3803J141, Exp. 7/2016
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA   NDC 45963-304-09


recall_number: D-0395-2015
recall_initiation_date: 2015-02-10
report_date: 2015-03-11
classification: Class II
status: Terminated
recalling_firm: Actavis Elizabeth LLC
recalling_firm_normalized: actavis elizabeth
reason_for_recall: Failed Dissolution Specifications
code_info: Lot #: 2020E141, Exp 07/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only,  Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.


recall_number: D-0825-2016
recall_initiation_date: 2016-03-14
report_date: 2016-04-27
classification: Class II
status: Terminated
recalling_firm: Impax Laboratories, Inc.
recalling_firm_normalized: impax
reason_for_recall: Failed Impurities/Degradation Specifications
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10

code_info:
Lot # 112579, 112580, Exp 03/17; 111013A, Exp 04/16; 111014, Exp 05/16; 113292, 113332, 113386, 113387, Exp 07/17; 111671,111673, Exp 09/16; 113806, 113807, Exp 10/17; 111874, 111875, 111876, Exp 11/16


recall_number: D-0826-2016
recall_initiation_date: 2016-03-14
report_date: 2016-04-27
classification: Class II
status: Terminated
recalling_firm: Impax Laboratories, Inc.
recalling_firm_normalized: impax
reason_for_recall: Failed Impurities/Degradation Specifications
code_info: Lot #: 112565, Exp 03/17; 113458, Exp 08/17
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10


recall_number: D-0055-2025
recall_initiation_date: 2024-10-31
report_date: 2024-11-27
classification: Class II
status: Ongoing
recalling_firm: Noven Pharmaceuticals Inc
recalling_firm_normalized: noven
code_info: Lot # 95598, Exp 02/28/25
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA nationwide.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3

reason_for_recall:
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).


recall_number: D-1408-2014
recall_initiation_date: 2014-05-01
report_date: 2014-07-02
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
code_info: Lot # 34013122A, Exp 11/15
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

reason_for_recall:
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.


recall_number: D-172-2013
recall_initiation_date: 2012-12-04
report_date: 2013-03-06
classification: Class II
status: Terminated
recalling_firm: Amedra Pharmaceuticals LLC
recalling_firm_normalized: amedra
code_info: Lot 220839, exp 11/30/2013
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

reason_for_recall:
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.


recall_number: D-173-2013
recall_initiation_date: 2012-12-04
report_date: 2013-03-06
classification: Class II
status: Terminated
recalling_firm: Amedra Pharmaceuticals LLC
recalling_firm_normalized: amedra
code_info: Lot 220843, exp 11/30/2013
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

reason_for_recall:
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.


recall_number: D-171-2013
recall_initiation_date: 2012-12-04
report_date: 2013-03-06
classification: Class II
status: Terminated
recalling_firm: Amedra Pharmaceuticals LLC
recalling_firm_normalized: amedra
code_info: Lot 238316, exp 01/31/2014
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide and Puerto Rico.
drug_base_substance: dextroamphetamine
source: openfda
product_description:
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

reason_for_recall:
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.


recall_number: D-965-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-29
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: guanfacine
source: openfda
reason_for_recall:
Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs:  buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014;  OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014;  OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2

code_info:
guanFACINE HCl, Tablet, 1 mg has the following codes:   Pedigree: W002728, EXP: 4/30/2014;  Pedigree: AD39611_1, EXP: 4/30/2014;  Pedigree: W003791, EXP: 6/27/2014;  Pedigree: AD73525_13, EXP: 4/30/2014.


recall_number: D-711-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-22
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: guanfacine
source: openfda
reason_for_recall:
Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as    buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014;  AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014;  glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014;  ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60

code_info:
guanFACINE HCl Tablet, 2 mg has the following codes    Pedigree: AD21790_13, EXP: 5/1/2014;  Pedigree: W002999, EXP: 6/11/2014;  Pedigree: W003678, EXP: 6/25/2014;  Pedigree: AD60272_10, EXP: 5/22/2014.


recall_number: D-0324-2021
recall_initiation_date: 2021-03-31
report_date: 2021-04-14
classification: Class II
status: Ongoing
recalling_firm: Apotex Corp.
recalling_firm_normalized: apotex
code_info: Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the United States
drug_base_substance: guanfacine
source: openfda
product_description:
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

reason_for_recall:
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate


recall_number: D-895-2014
recall_initiation_date: 2013-07-02
report_date: 2014-01-29
classification: Class II
status: Terminated
recalling_firm: Aidapak Services, LLC
recalling_firm_normalized: aidapak services
product_description: guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
drug_base_substance: guanfacine
source: openfda
reason_for_recall:
Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs:  glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014;  FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014;  chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014;  guanFACINE HCl,

code_info:
guanFACINE HC, Tablet, 1 mg has the following codes:   Pedigree: AD46265_25, EXP: 5/15/2014;  Pedigree: AD46414_22, EXP: 5/16/2014;  Pedigree: AD70629_7, EXP: 5/29/2014;  Pedigree: W003007, EXP: 6/12/2014.


recall_number: D-0149-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.

reason_for_recall:
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.


recall_number: D-0112-2025
recall_initiation_date: 2024-10-25
report_date: 2024-12-11
classification: Class II
status: Terminated
recalling_firm: Lannett Company Inc.
recalling_firm_normalized: lannett company
code_info: Lot: 23274856A, Exp 04/30/2025
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:  0527-4661-37

reason_for_recall:
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.


recall_number: D-0148-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.

reason_for_recall:
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.


recall_number: D-0516-2025
recall_initiation_date: 2025-06-16
report_date: 2025-07-23
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot # AD42648, Exp 02/28/2026
voluntary_mandated: Voluntary: Firm initiated
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 60 mg,	CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

reason_for_recall:
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

distribution_pattern:
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.


recall_number: D-0150-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.

reason_for_recall:
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.


recall_number: D-0599-2025
recall_initiation_date: 2025-08-11
report_date: 2025-09-03
classification: Class II
status: Completed
recalling_firm: Lannett Company Inc.
recalling_firm_normalized: lannett company
code_info: Lot #: 25280726A, Exp. Date 03/2027
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide within the USA
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

reason_for_recall:
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.


recall_number: D-0145-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.


recall_number: D-0144-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.


recall_number: D-0147-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.


recall_number: D-0146-2026
recall_initiation_date: 2025-10-28
report_date: 2025-11-05
classification: Class II
status: Ongoing
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
code_info: Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: U.S Nationwide.
drug_base_substance: lisdexamfetamine
source: openfda
product_description:
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.


recall_number: D-0142-2020
recall_initiation_date: 2019-10-04
report_date: 2019-10-23
classification: Class III
status: Terminated
recalling_firm: KVK-Tech, Inc.
recalling_firm_normalized: kvk-tech
reason_for_recall: Presence of Foreign Substance; Fiber particles.
code_info: Batch # 15315A, Exp. 02/2021
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the U.S.
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.


recall_number: D-0573-2022
recall_initiation_date: 2022-02-07
report_date: 2022-03-02
classification: Class II
status: Ongoing
recalling_firm: RISING PHARMACEUTICALS
recalling_firm_normalized: rising
code_info: lot# 25910009, Exp 01/2023
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01

reason_for_recall:
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.


recall_number: D-0940-2023
recall_initiation_date: 2023-07-13
report_date: 2023-08-02
classification: Class II
status: Terminated
recalling_firm: SUN PHARMACEUTICAL INDUSTRIES INC
recalling_firm_normalized: sun pharmaceutical industries
reason_for_recall: Presence of Foreign Substance: Metal embedded in a tablet.
code_info: Lot AC74459, Exp 07/31/2024
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.


recall_number: D-0110-2018
recall_initiation_date: 2017-12-18
report_date: 2017-12-27
classification: Class III
status: Terminated
recalling_firm: Osmotica Pharmaceutical Corp
recalling_firm_normalized: osmotica
reason_for_recall: Subpotent Drug
code_info: Lot #: 170027A, Exp. 02/2019
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles,  Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10


recall_number: D-0579-2024
recall_initiation_date: 2024-06-17
report_date: 2024-07-10
classification: Class II
status: Terminated
recalling_firm: Trigen Laboratories
recalling_firm_normalized: trigen
code_info: Lot 230159M, Exp Date 2/28/2026
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

reason_for_recall:
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.


recall_number: D-849-2013
recall_initiation_date: 2013-06-18
report_date: 2013-08-14
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA, Inc.
recalling_firm_normalized: teva
code_info: 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

reason_for_recall:
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.


recall_number: D-847-2013
recall_initiation_date: 2013-06-18
report_date: 2013-08-14
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA, Inc.
recalling_firm_normalized: teva
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

reason_for_recall:
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

code_info:
34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.


recall_number: D-848-2013
recall_initiation_date: 2013-06-18
report_date: 2013-08-14
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA, Inc.
recalling_firm_normalized: teva
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

reason_for_recall:
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

code_info:
34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.


recall_number: D-0837-2020
recall_initiation_date: 2020-01-27
report_date: 2020-02-19
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: CGMP deviations: Product bottle may be absent of desiccant.
code_info: Lot # 1332799A, Exp 11/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01


recall_number: D-0836-2020
recall_initiation_date: 2020-01-27
report_date: 2020-02-19
classification: Class II
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: CGMP deviations: Product bottle may be absent of desiccant.
code_info: Lot #: 1332796 A, Exp 11/2020
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: USA Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01


recall_number: D-0111-2018
recall_initiation_date: 2017-12-18
report_date: 2017-12-27
classification: Class III
status: Terminated
recalling_firm: Osmotica Pharmaceutical Corp
recalling_firm_normalized: osmotica
reason_for_recall: Subpotent Drug
code_info: Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807,  NDC 13811-709-10


recall_number: D-0581-2018
recall_initiation_date: 2018-02-28
report_date: 2018-03-14
classification: Class III
status: Terminated
recalling_firm: Osmotica Pharmaceutical Corp
recalling_firm_normalized: osmotica
code_info: Lots: 170231B, 170232A, 170233A, 170234A
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10

reason_for_recall:
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.


recall_number: D-0052-2018
recall_initiation_date: 2017-10-17
report_date: 2017-11-01
classification: Class III
status: Terminated
recalling_firm: Teva Pharmaceuticals USA
recalling_firm_normalized: teva
reason_for_recall: Failed Dissolution Specifications: Low out of specification results for dissolution.
code_info: Lot Number # 1156086M, Exp 08/18
voluntary_mandated: Voluntary: Firm initiated
distribution_pattern: Nationwide in the USA and Puerto Rico
drug_base_substance: methylphenidate
source: openfda
product_description:
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA  92880 USA, NDC 0591-5884-01.


