MedicineWatch US
Class II Recall

Direct Rx

Product
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
Reason
cGMP deviations
Classification
Class II
Status
Terminated
Lot
a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 .
Date
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.