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Prescription Drugs

💊 Drugs • 12,141 recalls

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

Ascend Laboratories

Class I - Dangerous

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Mar 14, 2023 Prescription Drugs Nationwide View Details →

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

Apollo Care

Class I - Dangerous

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Feb 8, 2023 Prescription Drugs View Details →

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

Ascend Laboratories

Class I - Dangerous

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Mar 14, 2023 Prescription Drugs Nationwide View Details →

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 →

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 →

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