Drug product
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
D-0483-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51 bottles
- Official record key
drug-enforcement:D-0483-2023
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations