Drug product
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
D-0451-2025
Product summary
- Event
- Event 96861
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,696 bottles
- Official record key
drug-enforcement:D-0451-2025
Official wording
Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Code information: Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations