The US arm of domestic pharma major Lupin Ltd is voluntarily recalling one lot of its diabetes treatment drug metformin hydrochloride extended-release tablets in the US market on account of the excess presence of a substance that could cause cancer.
Lupin Pharmaceuticals Inc is voluntarily recalling one lot of metformin hydrochloride extended-release tablets of 500 mg each, the company said in an announcement posted on the website of the US Food and Drug Administration (USFDA).
An FDA analysis showed that this lot exceeded the acceptable daily intake limit for the impurity N-Nitrosodimethylamine (NDMA).
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.
"To date, Lupin Pharmaceuticals Inc has not received any reports of adverse events related to this recall," the company said.
Metformin hydrochloride extended-release tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus, it added.
The company is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot, Lupin Pharmaceuticals Inc said.
This recall is being conducted with the knowledge of the USFDA, it added.
Lupin Pharmaceuticals Inc is the US-based wholly-owned subsidiary of Indian pharma major Lupin Ltd.
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