D-0577-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2025
- Initiation Date
- August 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,328 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026