Drug product
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
D-0558-2023
Product summary
- Event
- Event 92081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 bottles
- Official record key
drug-enforcement:D-0558-2023
Official wording
Reason: CGMP deviations.
Code information: Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP deviations