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Cadila Healthcare’s arm recalling 21,000 bottles of metformin hydrochloride extended-release tablets

05 Jul 2021 Evaluate

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.

Peers
Company Name CMP
Sun Pharma. Inds. 1745.00
Dr. Reddys Labs. 1242.00
Cipla 1331.00
Lupin 1953.75
Zydus Lifesciences 1113.00
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