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Cholesterol Medication Recalls

Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.

161 recalls in this category, newest first.

Class II · Moderate risk Ongoing Mar 23, 2023

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7631-9 D-0512-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7630-9 D-0511-2023

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0060-01 D-0503-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1311-01 D-0502-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0375-03 D-0501-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-3519-00 D-0500-2023

Class II · Moderate risk Terminated Mar 20, 2023

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1977-00 D-0498-2023

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0064-01 D-0496-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-3519-00 D-0495-2023

Class II · Moderate risk Terminated Mar 20, 2023

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1946-00 D-0491-2023

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 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 Feb 7, 2023

Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-011-15 D-0424-2023

Class II · Moderate risk Terminated Feb 7, 2023

Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-010-17 D-0423-2023

Class II · Moderate risk Terminated Feb 7, 2023

Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-009-15 D-0422-2023

Class II · Moderate risk Terminated Feb 7, 2023

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b)…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-008-15 D-0421-2023

Class II · Moderate risk Terminated Feb 7, 2023

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-007-15 D-0412-2023

Class II · Moderate risk Terminated Feb 7, 2023

Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-006-15 D-0411-2023

Class II · Moderate risk Terminated Feb 7, 2023

Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-005-15 D-0410-2023