Drug Safety Alerts

Marksans Metformin Hydrochloride Extended-Release 500 mg Tablets Consumer-Level Recall

6/05/2020

On June 5, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Metformin Hydrochloride Extended-Release 500 mg tablets NDC #49483-0623-01 manufactured by Marksans and distributed by Time-Cap Labs. This recall was issued because FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96 ng/day.

This could be a health hazard or safety risk to patients using product affected by this recall.

This recall affects lot number XP9004 exp. 12/2020.

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 Metformin Hydrochloride Extended-Release tablets are advised by the FDA to continue taking their medication and contact their health care professional who can prescribe a replacement. 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:

Please note: This product is not carried by CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Time-Cap Labs Inc. at 1-877-376-4271. 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.