Cadila Healthcare arm recollects 21,240 bottles of diabetes drug in US

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NEW DELHI : Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets manufactured by Cadila Healthcare of Ahemdabad, according to the latest enforcement report from the US Food and Drug Administration (USFDA).

Metformin hydrochloride prolonged-release tablets are indicated as a supplement to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Viona Pharmaceuticals Inc is recalling 21,240 bottles of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, due to “CGMP Deviations: FDA Analysis Detected N-Nitrosodimethylamine (NDMA) Levels Above Acceptable Daily Intake Limit”, the report said the said the US health authority.

The US nationwide voluntary recall is a Class II recall, he added.

According to the USFDA, a Class II recall is initiated in a situation where use or exposure to an injuring product may cause temporary or medically reversible health consequences, or the likelihood of serious health consequences is low.

NDMA is classified as likely to cause human cancer based on the results of laboratory tests. It is a known environmental pollutant and is found in water and food, including meat, dairy products, and vegetables.

Viona Pharmaceuticals Inc is a wholly-owned indirect subsidiary of Cadila Healthcare.

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