Cadila Healthcare’s wholly-owned indirect subsidiary-- Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets, USP 750 mg, on account of ‘CGMP Deviations: FDA analysis detected n-nitrosodimethylamine (NDMA) levels in excess of the acceptable daily intake limit.’ The voluntary ongoing nationwide recall in the US is a class-II recall. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.