Drug product
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
D-0577-2025
Product summary
- Event
- Event 97370
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44,328 bottles
- Official record key
drug-enforcement:D-0577-2025
Official wording
Reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Code information: Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
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