Class II
Ongoing
Carvedilol Tablets, USP, 12.5 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 68462-164-05
This recall is currently active, issued August 20, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- August 6, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0587-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17, 496 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
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
Nationwide within the USA
Lot / Code Info
Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
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