This recall is being conducted out of an abundance of caution in line with the ongoing interaction with the US Food and Drug Administration on NDMA impurity levels.
As part of the ongoing assessment and continuation of the dialog with the USFDA, additional analysis revealed that certain tested batches were above the acceptable daily intake limit for the impurity N-Nitrosodimethylamine (NDMA).Out of an abundance of caution, Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of metformin hydrochloride extended-release tablets USP, 500mg and 1000mg to the consumer level.
"To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall," the drug major said on Wednesday (8 July).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Metformin hydrochloride extended-release tablets USP are a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.
Shares of Lupin were up 0.94% at Rs 879 on BSE. Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets.
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