Drug recall D-0594-2025
Product
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
Lots and codes
Lot #: T05693, Exp. Date 03/2026
Recall details
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN
- Quantity
- 26,628 cartons
- Distribution
- Product was distributed nationwide within the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 20, 2025
Related products
- Carvedilol – drug information
- NDC 0904-7306 Carvedilol · Carvedilol 6.25 mg/1 · Major Pharmaceuticals
- NDC 0904-7305 Carvedilol · Carvedilol 3.125 mg/1 · Major Pharmaceuticals
- NDC 0904-7307 Carvedilol · Carvedilol 12.5 mg/1 · Major Pharmaceuticals
- NDC 0904-7308 Carvedilol · Carvedilol 25 mg/1 · Major Pharmaceuticals