Drug Safety Alerts

Riomet® ER Consumer-Level Recall

9/24/2020

On September 24, 2020, Sun Pharmaceutical Industries, Inc. issued a consumer-level recall of one lot of RIOMET ER™ 500 mg/5 mL NDC #10631-0019-17. This recall was issued because the level of N-Nitrosodimethylamine (NDMA) was found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

This recall affects lot number AB06381 Exp. 10/2021. The lot number is located to the right of the barcode at the bottom of the drug label.

NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Metformin is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients taking recalled RIOMET ER™ 500 mg/5 mL are advised by the FDA to continue taking their medication and contact their health care professional for advice about an alternative treatment. According to the FDA it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking recalled RIOMET ER™ 500 mg/5 mL to contact their health care professional.

Sun Pharmaceutical Industries, Inc. at 1-800-818-4555, Monday through Friday from 8:00 AM to 5:00 PM (EST). You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.