Drug product
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
D-0579-2025
Product summary
- Event
- Event 97370
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,800 bottles
- Official record key
drug-enforcement:D-0579-2025
Official wording
Reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Code information: Lot#:19243104, Expires: 7/31/2026.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
nitrosamine, N-Nitroso Carvedilol I Impurity
-
Manufacturing or process control
CGMP Deviations