Drug major Lupin Ltd on Wednesday said it is voluntarily recalling its diabetes treatment drug Metformin Hydrochloride extended-release tablets in the US market. In a regulatory filing, the company said that it is voluntarily recalling its Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg products in the US.
“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,” the filing said. Lupin’s US subsidiary, Lupin Pharmaceuticals Inc, distributes Metformin Hydrochloride extended-release tablets USP in the strengths of 500 mg and 1000 mg in the US.
“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 US during the current quarter,” the company said.
Further, “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 all relevant regulatory norms,” it said.
The company said the “aforementioned products are part of a completely separate supply chain with respect to their Active pharmaceutical ingredient (API) source, formulation process and manufacturing sites”.
The impurity, N-Nitrosodimethylamine (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.
Metformin Hydrochloride extended-release tablets 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. Shares of Lupin were trading 0.64 per cent higher at Rs 876.35 apiece on BSE.