Lupin and Granules India are recalling close to 9.71 lakh bottles of generic diabetes drug in the US due to the 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 strengths.
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”.
Various companies across the globe have announced similar recalls for the product after the USFDA pointed out the 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 pharma ingredient.