Drug product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
D-0559-2023
Product summary
- Event
- Event 92081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 bottles
- Official record key
drug-enforcement:D-0559-2023
Official wording
Reason: CGMP deviations.
Code information: Lots: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP deviations