Lupin, Granules India Recall 9.71 Lakh Bottles of Diabetes Drug in US Market
added 26.07.2020 17:13
Various companies across the globe have announced similar recalls for the product after the USFDA pointed out presence of NDMA above permissible limits.
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 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.
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.
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.