Drug 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

D-0594-2025

August 20, 2025

Class II

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 97449
Status: Ongoing
Classification: Class II
Quantity: 26,628 cartons
Official record key: drug-enforcement:D-0594-2025

Official wording

Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Code information: Lot #: T05693, Exp. Date 03/2026

Distribution pattern: Product was distributed nationwide within the United States.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-Nitroso Carvedilol Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations