Sun Pharma arm recalls one lot of diabetes drug Riomet ER oral in US
The US arm of domestic pharma major Sun Pharma has said it is voluntarily recalling one lot of Riomet ER oral suspension in the US market, due to the presence of a probable human carcinogen above the acceptable daily intake limit.
Sun Pharmaceutical Industries Inc, a wholly-owned subsidiary of Sun Pharmaceutical Industries, is voluntarily recalling one lot of Riomet ER (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL to the consumer level, the company said in an announcement posted on the website of the United States Food and Drug Administration.
“The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable acceptable daily intake (ADI) limit established by the USFDA,” it added.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests, the announcement said.
It is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
To date, the company has not received any reports of adverse events related to this recall, it added.
The product was distributed nationwide to wholesale customers, Sun Pharmaceutical Industries Inc said.
The company is notifying its distributors and customers through its third-party recall coordinator, via FedEx standard overnight shipping and will arrange for the return of all recalled products, it added.
This recall is being conducted with the knowledge of the US Food and Drug Administration, Sun Pharmaceutical Industries Inc said.