Drug product
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
D-0217-2025
Product summary
- Event
- Event 96191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 247 blister packs
- Official record key
drug-enforcement:D-0217-2025
Official wording
Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Code information: Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Distribution pattern: FL
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Carvedilol Impurity
-
Manufacturing or process control
CGMP deviations