A recall has been issued for a popular drug used to control high blood sugar associated with type 2 diabetes. Manufactured by Marksan Pharma Limited and distriputed by Time-Cap Labs in New York State, Metformin Hydrochloride Extended Release Tablets, USP 500mg and 750mg have been found to contain a known carcinogen, N-Nitrosodimethylamine or NDMA.

The manufacturer has expanded a recall issued previously for the drug to now include another 76 lots of the drug. The unexpired lots were tested and it was found that they contained levels of NDMA higher than the acceptable daily intake limit which is 96 nanograms or 96 billionths of a single gram per day. According to a statement from 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. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

 

The medication impacted by the recall is a white or off-white "biconvex" tablet stamped on one side with either "101" or 102" and plain on the other side of the tablet depending on if it is 500mg or 750 mg, respectfully. The FDA advises consumers who have been prescribed this medication to continue taking until your doctor or pharmacist has given you a replacement and reminds consumers that it can be dangerous to stop taking this medication without talking with your doctor.

As a consumer, if you have questions about the recall or the process of returning the medication, your encouraged to contact Ms. Irene McGregor, Vice President, Regulatory Affairs of Time-Cap Labs, by phone (631)753-9090 ext. 160 or by email, imcgregor@timecaplabs.com

The full list of affected lot numbers of Metformin Hydrochloride Extended Release Tablets can be found on the FDA site.

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