D-0578-2025 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
- 6,432 bottles
Product Description
Carvedilol Tablets, USP, 12.5 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 68462-164-05
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#:19243202, Exp: 7/31/2026.