Sun Pharma issues recall of its generic diabetes drug in US market

pharmafile | October 12, 2020 | News story | Sales and Marketing |  FDA, diabetes, recall 

Sun Pharma is recalling 747 bottles of its generic diabetes drug Riomet ER in the US.

This is due to an enforcement by the FDA, which has stated that the company’s product has deviated from the current good manufacturing practices due to a detection of N-nitrosodimethylamine (NDMA) impurity in the product. 

The FDA classifies NDMA as a probable human carcinogen based on results from lab tests, as well as an environmental contaminant found in water and food. So far, Sun Pharma has not received any reports of its diabetes drug causing adverse effects due to the presence of NDMA. 

The regulatory body has classified it as Class-2 recall, which is initiated due to the use of or exposure to a violative product that may cause temporary or medically reversible adverse health consequences or raise the probability of serious adverse health consequences. 

Riomet ER is metformin hydrochloride and a prescription of oral medication is given to type 2 diabetics to improve blood glucose control. The FDA’s testing showed elevated levels of NDMA in some extended-release metformin formulations, but not in the immediate-release formula or in the active pharmaceutical ingredients.

Multiple companies have also recalled their products after the FDA found evidence that there were amounts of NDMA above acceptable quantities. In July, Lupin and Granules India recalled close to 971,000 bottles of its generic diabetes drugs in the US for a similar reason to Sun Pharma. 

Conor Kavanagh