Lupin to voluntarily recall its Metformin Hydrochloride extended-release tablets

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride extended-release tablets USP, 500 mg and 1,000 mg to the consumer level.

As part of the ongoing assessment and continuation of the dialogue with the Food and Drug Administration (FDA), additional analysis revealed that certain tested batches were above the acceptable daily intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA).

Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride extended-release tablets USP, 500 mg and 1,000 mg in the United States. To date, Lupin Pharmaceuticals Inc. has not received any specific report of adverse events relating to this recall.

NDMA is a probable human carcinogen i.e., a substance that could cause cancer, based on results from laboratory tests. NDMA is also an environmental contaminant and is found in water and food, including meats, dairy products and vegetables.

Metformin Hydrochloride extended-release tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise in order to improve blood glucose control in adults with type 2 diabetes mellitus.

Metformin Hydrochloride extended-release tablets USP, 500 mg and 1,000 mg is packaged in 60, 90 and 100 count bottles and distributed nationwide in the United States to wholesalers, distributors, drug chains, mail order pharmacies and supermarkets.

The stock closed at 865.35, down by 0.63 per cent or Rs 5.45 per share. The intraday high is Rs 889.15 and intraday low is Rs 861.70.