Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets manufactured by Ahemdabad-based Cadila Healthcare, the latest enforcement report of the US Food and Drug Administration (USFDA) said.
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.
Viona Pharmaceuticals Inc is recalling 21,240 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 report by the US health regulator said.
The voluntary ongoing nationwide recall in the US is a class-II recall, it added.
As per USFDA, a class-II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Viona Pharmaceuticals Inc is a wholly-owned indirect subsidiary of Cadila Healthcare.
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