US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 13, 2023 (3 years ago)

Simvastatin

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations

What was recalled

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

Recalling firm
Direct Rx
NDC code
61919-0688-30
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0484-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Simvastatin recalls

See all
Class III · Low risk Ongoing

Ezetimibe and Simvastatin Tablets

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Glenmark Pharmaceuticals Inc., USA NDC 68462-323-90 D-0462-2025
Class II · Moderate risk Terminated

Simvastatin USP 40 mg

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0726-30 D-0561-2023
Class II · Moderate risk Terminated

Simvastatin USP 20 mg

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-008-30 D-0560-2023
Class II · Moderate risk Terminated

Simvastatin USP

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023
Class II · Moderate risk Ongoing

Simvastatin Tablets

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

Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023