D-0588-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2025
- Initiation Date
- August 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,976 bottles
Product Description
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Reason for Recall
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026