After several recalls were issued for the diabetes drug metformin, Sun Pharmaceutical Industries (SNSS) has issued a recall for RIOMET ER – metformin hydrochloride for extended-release oral suspension medication – because it may contain higher than acceptable levels of a cancer-causing ingredient – Nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen that could cause cancer. It was found in RIOMET ER, a drug used to regulate glycemic levels in adults and pediatric patients that have Type 2 diabetes mellitus , in levels that are above the allowable acceptable daily intake limit set by the U.S. Food and Drug Administration.
The recall affects 500 mg per 5 mL doses of the diabetes medication, which was packaged in 16-ounce round bottles and distributed nationwide. Each carton of the medication contains one bottle of drug pellets, one bottle of diluent, and one dosing cup. It also has a lot code of AB06381 and an NDC number of 10631-019-17. The expiration date is 10/2021.
Labels of the recalled metformin medication can be viewed here.
Questions about the recall can be directed to Sun Pharmaceuticals at 1-800-818-4555, Monday through Friday from 8 a.m. to 5 p.m. EST or by email at [email protected].
Patients that take RIOMET ER should continue taking the medication and contact their healthcare provider for an alternative course of treatment. The FDA said it could be dangerous for people to stop taking the affected metformin medication without talking to their healthcare provider first.
Patients that experience issues related to the recalled medication should contact their physician. Sun Pharmaceuticals said it has not received any reports of adverse reactions from the recalled RIOMET ER medication.
Shares of Sun Pharmaceuticals were trading at $1.23 as of 10:02 a.m. EDT, down 2 cents or 1.60%.