Drug product

Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05

D-0587-2025

August 06, 2025

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 97372
Status: Ongoing
Classification: Class II
Quantity: 17, 496 bottles
Official record key: drug-enforcement:D-0587-2025

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 #: 17241257, 17241258, 17241279, Exp. Date 06/2026

Distribution pattern: Nationwide within the USA

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