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 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 US Food and Drug Administration.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. To date, SUN PHARMA has not received any reports of adverse events related to this recall.
RIOMET ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and paediatric patients 10 years of age and older with type 2 diabetes mellitus.
Sun Pharma is notifying its distributors and customers through its third party Recall Coordinator (Inmar Inc), via FedEx standard overnight shipping and will arrange for return of all recalled products.