Class II
Ongoing
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
This recall is currently active, issued August 27, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- August 20, 2025
- Posted
- August 27, 2025
- Recall Number
- D-0594-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 26,628 cartons
- Firm Location
- La Vergne, TN, 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
Product was distributed nationwide within the United States.
Lot / Code Info
Lot #: T05693, Exp. Date 03/2026
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