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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

RemedyRepack

Class I - Dangerous

cGMP Deviations

Mar 20, 2023 Prescription Drugs Nationwide View Details →

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack

Class I - Dangerous

cGMP Deviations

Mar 20, 2023 Prescription Drugs Nationwide View Details →

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

RemedyRepack

Class I - Dangerous

cGMP Deviations

Mar 20, 2023 Prescription Drugs Nationwide View Details →

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.

Endo Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.

Mar 2, 2023 Prescription Drugs Nationwide View Details →

Ropinirole, USP, 0.25 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 →

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

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 →