Drug Safety Alerts

Metformin Hydrochloride Extended-Release 750 mg Tablets Consumer-Level Recall

1/7/2022

On January 7, 2022, Viona Pharmaceuticals, Inc. issued consumer-level recall of Metformin Hydrochloride Extended-Release 750 mg tablets, NDC # 72578-0036-01, manufactured by Cadila Healthcare and distributed by Viona Pharmaceuticals. This recall was issued due to observation of an out of specification result for lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure, the company is recalling all marketed lots having valid shelf life.

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

A list of the affected products is provided here.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Viona Pharmaceuticals, Inc. has advised that as of the date of its announcement, it has not received any reports of adverse events that have been related to this recall.

Viona Pharmaceuticals, Inc. advises that patients taking these recalled product lots of Metformin ER Tablets should contact their healthcare professional to obtain a replacement or alternative treatment option, and that it could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Viona Pharmaceuticals, Inc. further advises that consumers should contact their physician if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service and Specialty Pharmacies and their physicians.

For more information, please contact Viona Pharmaceuticals, Inc. at 1-888-304-5011 Monday through Friday, 9:00 AM to 5:00 PM (EST) or visit https://vionausa.com.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.