Drug product
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
D-0557-2023
Product summary
- Event
- Event 92081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 352 bottles
- Official record key
drug-enforcement:D-0557-2023
Official wording
Reason: CGMP deviations.
Code information: Lots: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP deviations