Drug product
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
D-0486-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 269 bottles
- Official record key
drug-enforcement:D-0486-2023
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: 28AP2212 , exp 7/31/2024 ; 24MA2230, exp 7/31/2024; 11JA2203 , exp 3/31/2023; 02FE2217 , exp 2/28/2023; 10DE2126 , exp 2/28/2023; 25MA2201, exp 5/31/2023; 28FE2230, exp 5/31/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations