Drug Recall List

Drug Recall List Drug

Recall Details

Last Updated: January 2022

Contact

Date

Drug Recall Class*

Lexette (halobetasol propionate) CGMP Deviation 05186260450

Clobazam 07778905804

Failed Stability Specifications

Clobetasol Propionate 05074230450 05074230401

Brinzolamide 00591212779 00591212712

CGMP Deviations Defective Container

If you have questions about this recall, Mayne Pharma Inc, 844 825 8500

January 2022

If you have questions about this recall, Ingenus Pharmaceuticals LLC, 877-530-1633.

January 2022

If you have questions about this recall, Ingenus Pharmaceuticals LLC, 1-407-354-5740

January 2022

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

January 2022

Class II

Class II

Class II

Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

8.4% Sodium Bicarbonate 05175450011

Metformin 70518292000

Norepinephrine Bitartrate 00703115303

Lack of Assurance of Sterility CGMP Deviations Lack of Assurance of Sterility

If you have questions about this recall, Exela Pharma Sciences LLC, 1888-451-4321 If you have questions about this recall, RemedyRepack Inc., 1866-845-3791 If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

January 2022

January 2022

January 2022

Class II

Class II

Class II

MethylPREDNISolone Acetate 01671409001

Lack of Assurance of Sterility

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

January 2022

Class II

Carbamazepine

Failed Dissolution Specifications

If you have questions

January Class

01366826801

about this recall,

2022

II

Torrent Pharma Inc, 1-

888-280-2040.

Clobetasol Propionate

Microbial Contamination of Non-

If you have questions

January Class

05167212593

Sterile Products

about this recall, Taro

2022

I

Pharmaceuticals U.S.A.,

Inc.,1-800-544-1449 ext

6066.

* Drug Recall Class

Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death.

Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious

adverse health consequences is remote.

Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Pregabalin 04733568788

Lidocaine Hydrochloride 06373999764

Lidocaine Hydrochloride 06373999764

Betamethasone Dipropionate 05256502329

Penicillin V Potassium 00093412573 00093412574

Fexofenadine Hydrochloride 00904697940

Failed Tablet/Capsule Specifications Superpotent Drug

If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800818-4555 If you have questions about this recall, Teligent Pharma, 1-856-697-1441

January 2022

January 2022

Class II

Class II

Superpotent Drug

If you have questions about this recall, Teligent Pharma, 1-856-697-1441

January 2022

Class I

Failed Stability Specifications

If you have questions about this recall, Teligent Pharma, 1-856-697-1441

January 2022

Class II

Subpotent

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

December Class

2021

II

Failed Impurities/Degradation Specifications

If you have questions about this recall, The Harvard Drug Group, 1800-875-0123.

December Class

2021

II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Clindamycin and Benzoyl Peroxide Gel 00781726368

Lidocaine Hydrochloride 05256500950

Lidocaine Hydrochloride 06373999764 05256500950

Cefixime 70518274902

Diclofenac Sodium 68788770701

Superpotent Drug Superpotent Drug CGMP Deviations

Failed Impurities/Degradation Specifications Defective container

Hydrocodone Bitartrate and Acetaminophen 03172299701

Product Mix-up

If you have questions about this recall, TOLMAR, Inc., 1-970-2124500 If you have questions about this recall, Teligent Pharma, 1-856-697-1441

December 2021

December 2021

Class II

Class I

If you have questions about this recall, Teligent Pharma, 1-856-697-1441

December Class

2021

II

If you have questions about this recall, RemedyRepack Inc., 1866-845-3791 If you have questions about this recall, Preferred Pharmaceuticals, Inc., 1714-777-3729 If you have questions about this recall, Ascent Pharmaceuticals, Inc., 1-631-851-0550

December Class

2021

II

December Class

2021

II

December Class

2021

II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Cefixime 06787758450

Ascorbic Acid

Diclofenac Sodium 05266500205 05266502505

Flocinolone Acetonide 06516270486 06516270386

Cefixime 06787758450

Tadalafil 01671407501 01671407701

Failed impurities/degradation specifications Lack of Assurance of Sterility

Defective Container

Subpotent Drug

Failed Impurities/Degradation Specifications

Incorrect Product Formulation

If you have questions about this recall, Ascend Laboratories, LLC, 1-201-476-1977 If you have questions about this recall, ASP Cares, 1-210-615-7400

December 2021

December 2021

Class II

Class II

If you have questions about this recall, Teligent Pharma, 1-856-697-1441

December Class

2021

II

If you have questions about this recall, Amneal Pharmaceuticals., 1-833582-0812. If you have questions about this recall, Ascend Laboratories LLC, 1-201-476-1977

December 2021

November 2021

Class II

Class II

If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800818-4555

November 2021

Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ezetimibe and Simvastatin 05140719305

Ezetimibe and Simvastatin 05140719290 05140719205

Methocarbamol 07133517952 07133517954 07133517957

Irbesartan and Hydrochlorothiazide 06818041306 06818041309 06818041406 06818041409

Irbesartan 06818041006 06818041009 06818041106 06818041109 06818041206 06818041209

Failed Excipient Specification

cGMP Deviations

Labeling: Label Error on Declared Strength

If you have questions about this recall, Dr. Reddy's Laboratories, Inc., 1-888-375-3784 If you have questions about this recall, Dr. Reddy's Laboratories, Inc., 1-888-375-3784 If you have questions about this recall, 1-877885-0882.

November Class

2021

II

November Class

2021

II

November Class

2021

I

CGMP Deviations

If you have questions about this recall, Lupin Pharmaceuticals Inc.1410-576-2000 ext 3

November Class

2021

II

CGMP Deviations

If you have questions about this recall, Lupin Pharmaceuticals Inc.1410-576-2000 ext 3

November Class

2021

II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

Ezetimibe and Simvastatin 04359874290 04359874210 04359874430 04359874490 04359874530 04359874590 04359874505 04359874330 04359874390 04359874305

Failed Excipient Specifications

If you have questions about this recall, Dr. Reddy's Laboratories, Inc., 1-888-375-3784

November Class

2021

II

Rocuronium Bromide 66794022841

Imipramine Pamoate

Omeprazole Delayed-Release 07000002321

Labeling: Label Lacks Warning or Rx Legend

Out of specification result observed in a dissolution test

If you have questions about this recall, Piramal Critical Care, Inc. 1-800-414-1901 If you have questions about this recall, Lupin Pharmaceuticals Inc.1410-576-2000 ext 3

October 2021

October 2021

CGMP Deviations

If you have questions about this recall, Dr. Reddy's Laboratories, Inc., 1-888-375-3784

October 2021

Class II

Class II

Class II

* Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

AirDuo Digihaler 232/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931013606

Subpotent drug

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

October 2021

Class II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931012906

Subpotent drug

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

October 2021

Class II

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) 05931011106

Subpotent drug

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

October 2021

Class II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) 05931053008

Subpotent drug

If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800

October 2021

Class II

AirDuo Digihaler 113/14

Subpotent drug

If you have questions

October Class

(fluticasone propionate 113 mcg

about this recall,

2021

II

and salmeterol 14 mcg)

Teva Pharmaceuticals

05931052008

USA,

1-800-545-8800

* Drug Recall Class

Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death.

Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious

adverse health consequences is remote.

Class 3 Recall: Using the drug is not likely to cause adverse health consequences.

NOTE: This is not a complete list of all recalls. Please see >Drugs>Drug Safety and Availability> Drug Recalls for additional information.

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