Sun Pharma is recalling 747 bottles of generic diabetes drugs in the US due to the possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit, the US health regulator has said.
As per the latest Enforcement Report of the US Food and Drug Administration (US FDA), Sun Pharmaceutical Industries is recalling the bottles of RIOMET ER (metformin hydrochloride for extended-release oral suspension) in the American market.
As per the US FDA, 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 products.
The product has been manufactured at Sun Pharma’s Mohali-based manufacturing plant and is being recalled by its US-based subsidiary.
The company initiated the recall on September 23, the US FDA said.
The US 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 US FDA pointed out the 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 drugs in the US 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 US FDA said Strides Pharma, a unit of Bengaluru-based Strides Pharma Science, is recalling 11,280 bottles of Potassium Chloride extended-release rablets due to “failed dissolution specifications”.