Sun Pharmaceutical Industries Limited (Sun Pharma), an Indian multinational pharmaceutical firm, has reportedly recalled 747 bottles of generic diabetes drugs in the United States due to the probability of the affected lot containing cancer-causing NDMA (N-Nitrosodimethylamine) above the permissible intake limit. The product has been developed at the firm’s Mohali-based manufacturing facility and is being recalled by its American subsidiary.

 The recent Enforcement Report of the US FDA (Food and Drug Administration) stated that Sun Pharma is recalling RIOMET ER (metformin hydrochloride for extended-release oral suspension) bottles in the U.S market. The agency said that the firm commenced the recall on 23 September.

Sources cite that it is a Class-2 recall, which is commenced in a ‘situation in which use or exposure to the violative drug could cause medically reversible or temporary adverse health consequences or where the possibility of severe adverse health consequences is remote. RIOMET ER is a prescription oral drug directed as an adjunct to exercise and diet to enhance blood glucose control in adult patients with type-2 diabetes mellitus.

Numerous companies worldwide have announced similar recalls for the drug after the U.S health regulator pointed out the presence of NDMA above acceptable limits. In July 2020, Lupin Limited and Granules India had recalled around 9.71 lakh generic diabetes drugs bottles in the United States for the same reason.

For the record, NDMA is categorized as a possible human carcinogen based on outcomes from laboratory tests. It is an identified environmental contaminant and found in food and water, including meats, vegetables, and dairy products.

Meanwhile, in a separate note, the U.S health regulator stated that Strides Pharma Inc., the U, S subsidiary of India-based Strides Pharma Science Ltd, is recalling 11,280 bottles of Potassium Chloride extended-release tablets. The Class II recall was commenced by the firm on August 24.

Source credit - https://medicaldialogues.in/news/industry/pharma/sun-pharma-recalls-747-bottles-of-generic-diabetes-drug-in-us-over-cancer-causing-impurity-70403