Status
Ongoing
Drug Enforcement D-0594-2025
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Classification
Class II
Report Date
August 27, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 26,628 cartons
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed nationwide within the United States.
Location & Firm
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Address
-
341 Mason Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0594-2025
- Event ID
- 97449
- Recall initiation date
- August 20, 2025
- Center classification date
- August 21, 2025
- Code info
- Lot #: T05693, Exp. Date 03/2026
- More code info
- —