FDAHealthAugust 20, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals
⚠️ CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 20, 2025
Product was distributed nationwide within the United States.
What's affected?
- 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
- Brand
- CARVEDILOL
- Lot code
- T05693
Additional details
Lot #: T05693, Exp. Date 03/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26,628 cartons.
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