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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

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

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of specification for shear.

Mar 10, 2023 Prescription Drugs Nationwide View Details →

JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA

Boehringer Ingelheim Pharmaceuticals

Class I - Dangerous

Labeling: Label Mix-up

Mar 9, 2023 Prescription Drugs Nationwide View Details →

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.

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of specification for shear.

Mar 10, 2023 Prescription Drugs Nationwide View Details →

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

Global Pharma Healthcare Private Limited

Class I - Dangerous

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Feb 24, 2023 Other Drugs Nationwide View Details →

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

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of specification for shear.

Mar 10, 2023 Prescription Drugs Nationwide View Details →

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Content Uniformity Specifications

Mar 9, 2023 Prescription Drugs Nationwide View Details →

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.

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of specification for shear.

Mar 10, 2023 Prescription Drugs Nationwide View Details →

Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

Feb 24, 2023 Prescription Drugs View Details →

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Potential risk of Cross Contamination

Mar 2, 2023 Prescription Drugs Nationwide View Details →

Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Potential risk of Cross Contamination

Mar 2, 2023 Prescription Drugs Nationwide View Details →

Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Potential risk of Cross Contamination

Mar 2, 2023 Prescription Drugs Nationwide View Details →

Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05

AVEVA Drug Delivery Systems

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

Feb 15, 2023 Prescription Drugs Nationwide View Details →

Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05

AVEVA Drug Delivery Systems

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

Feb 15, 2023 Prescription Drugs Nationwide View Details →

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27

Padagis US

Class I - Dangerous

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

Feb 21, 2023 Prescription Drugs Nationwide View Details →