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FDA Drug Recalls

1,122 recalls, newest first

Class II · Moderate risk Ongoing Mar 17, 2023

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason Out of specification (OOS) for Spectroscopic Identification test by IR.

Ascend Laboratories, LLC D-0539-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-487-52 D-0554-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-473-87 D-0553-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-120-52 D-0552-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-383-52 D-0551-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-109-52 D-0550-2023

Class II · Moderate risk Ongoing Mar 16, 2023

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-511-52 D-0549-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-946-52 D-0548-2023

Class II · Moderate risk Terminated Mar 16, 2023

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by…

Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.

Amerisource Health Services LLC D-0536-2023

Class III · Low risk Ongoing Mar 16, 2023

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for…

Reason Labeling; Incorrect NDC number on outer carton of product.

Focus Health Group Inc D-0535-2023

Class II · Moderate risk Completed Mar 15, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0411-04 D-0543-2023

Class II · Moderate risk Completed Mar 15, 2023

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0409-07 D-0542-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

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

Ascend Laboratories, LLC NDC 67877-475-60 D-0534-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

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

Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc…

Reason CGMP Deviations: Discoloration

Hetero USA Inc NDC 31722-713-10 D-0530-2023

Class I · High risk Ongoing Mar 13, 2023

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc…

Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged…

Camber Pharmaceuticals Inc. NDC 31722-629-21 D-0567-2023

Class II · Moderate risk Terminated Mar 13, 2023

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

Reason cGMP deviations

Direct Rx NDC 61919-0431-90 D-0486-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0446-30 D-0485-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle…

Reason cGMP deviations

Direct Rx NDC 61919-0688-30 D-0484-2023

Class II · Moderate risk Terminated Mar 13, 2023

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

Reason cGMP deviations

Direct Rx NDC 61919-0710-90 D-0483-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0250-30 D-0482-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0488-30 D-0481-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0723-30 D-0480-2023

Class II · Moderate risk Terminated Mar 13, 2023

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

Reason cGMP deviations

Direct Rx NDC 72189-0364-30 D-0479-2023

Class II · Moderate risk Terminated Mar 13, 2023

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct…

Reason cGMP deviations

Direct Rx NDC 72189-0364-30 D-0478-2023