Drug makers Lupin and Granules India are recalling close to 9.71 lakh bottles of generic diabetes drug in the US due to possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit.
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Lupin is recalling 4,92,858 bottles of Metformin Hydrochloride extended-release tablets in 500 mg and 1,000 mg strengths. On the other hand, Hyderabad-based Granules India is recalling over 4.78 lakh bottles of the drug in 750 mg strength.
As per the USFDA, the companies are recalling the product due to deviation from the current good manufacturing practices (CGMP). “FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level,” it noted.
The USFDA has classified it as a Class-II recall, which is initiated in a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”. Lupin is recalling 1,23,912 bottles of the 500 mg Metformin Hydrochloride extended-release tablets and 3,68,946 bottles of the same drug of 1,000 mg strength.
The product has been manufactured at Lupin’s USFDA approved Goa-based manufacturing plant, and is being recalled by company’s US based subsidiary. Lupin sells Metformin Hydrochloride extended-release tablets under Gluconorm SR brand in India. The product is not impacted in the country as it is manufactured in a separate facility which caters to the domestic market, while there are specific plants which cater to the US market.
Granules India is recalling 4,78,173 bottles of the drug in the strength of 750 mg due to similar reasons. The company’s US-based arm is recalling the affected lots which have been manufactured in India.
Metformin Hydrochloride extended-release tablet 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. Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits.
FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation, but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient. 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 food, including meats, dairy products and vegetables.