Lupin is voluntarily recalling its Metformin Hydrochloride Extended-ReleaseTablets USP, 500mg and 1000mg products in the U.S. This recall is being conducted out of an abundance of caution in line with the ongoing interaction with the U.S. Food and Drug Administration on NDMA impuritylevels.

Lupin's U.S. subsidiary Lupin Pharmaceuticals Inc. distributes Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the U.S. The company said, 'We believe that the issues identified in the concerned products are addressable and we expect to re-introduce our updated Metformin Hydrochloride Extended-Release Tablet product(s) in the U.S. during the current quarter.'

'We wish to separately clarify that all of the company's Metformin products manufactured and marketed in India have been tested for NDMA levels and have been assessed to be safe for patients and comply with allrelevant regulatory norms. Further, these aforementioned products are part of a completely separate supply chain with respect to their API source, formulation process and manufacturing sites', said the company.

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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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Lupin has allotted 31012 fully paid-up equity shares of s 2/- each. These shares have been allotted upon exercising ofoptions granted to the employees under Stock option plans of the Company.

In view of the above, the issued and paid-up capital of the Company has been increased to s 90,61,82,044consisting 45,30,91,022 equity shares of s 2/- each.

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Lupin announced that it has receivedapproval for its Albendazole Tablets USP, 200 mg, from the United States Food and Drug Administration (U.S.FDA), to market a generic equivalent of Albenza® Tablets, 200 mg, of Impax Laboratories Inc.

Albendazole Tablets USP, 200 mg, are an anthelmintic drug indicated for treatment of:
• Parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm
• Cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm

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