D-0594-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2025
- Initiation Date
- August 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,628 cartons
Product Description
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
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
Product was distributed nationwide within the United States.
Code Information
Lot #: T05693, Exp. Date 03/2026