Drug product
Simvastatin USP 40 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 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
D-0561-2023
Product summary
- Event
- Event 92081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393 bottles
- Official record key
drug-enforcement:D-0561-2023
Official wording
Reason: CGMP deviations.
Code information: Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP deviations