As per the latest Enforcement Report of the U.S. Food and Drug Administration (USFDA), Sun Pharmaceutical Industries is recalling the bottles of RIOMET ER (metformin hydrochloride for extended-release oral suspension) in the American market.
As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP) — detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
The product has been manufactured at Sun Pharma’s Mohali-based manufacturing plant and is being recalled by its U.S.-based subsidiary.
The company initiated the recall on September 23, the USFDA said.
The U.S. health regulator 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.”
Metformin Hydrochloride extended-release suspension 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.
In July this year, Lupin and Granules India had also recalled close to 9.71 lakh bottles of generic diabetes drug in the U.S. for the similar reason.
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.
In a separate note, the USFDA said Strides Pharma Inc, a unit of Bengaluru-based Strides Pharma Science Ltd, is recalling 11,280 bottles of Potassium Chloride extended-release rablets due to “failed dissolution specifications“.
The Class II recall was initiated by the company on August 24.