Direct Rx — Class II Recall

Product

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

Reason

cGMP deviations

Classification

Class II

Status

Terminated

Lot

a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.

Date

2023-04-05

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.