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
Reported: August 27, 2025 Initiated: August 20, 2025 #D-0594-2025
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
Details
- Units Affected
- 26,628 cartons
- Distribution
- Product was distributed nationwide within the United States.
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 26,628 cartons.
Why was this product recalled? ▼
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2025. Severity: Moderate. Recall number: D-0594-2025.
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