EXPANDED RECALL OF POPULAR DIABETES DRUG DUE TO HIGH LEVELS OF CANCER-CAUSING AGENT

Categories: Metformin Recall

Additional lots of the widely-used diabetes drug, metformin hydrochloride, have been recalled after they were found to contain unacceptably high levels of a cancer-causing contaminant.

Marksans Pharma Limited, India has voluntarily expanded its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg. The manufacturer performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots exceeded the acceptable Daily Intake Limit (ADI) of 96ng/day. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

This is just one of several metformin products that have been found to contain NDMA in the last year. Other pharmaceutical companies have issued recalls for metformin hydrochloride extended-release tablets due to their carcinogenic contents. The FDA currently publishes a recalled metformin list including details about metformin products that have been recalled.

In its 10/5/20 update, the FDA recommended that “patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.” The FDA further stated that its “testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).”

For more information about the recalls or regarding potential legal claims for individuals who have been diagnosed with cancer after taking one of the recalled products contact Borgess Law, LLC at (567) 455-5955. You can also contact Borgess Law by submitting an online inquiry. Attorney Pamela Borgess, the founder of Borgess Law, LLC, has decades of experience with numerous national high-profile defective medical drug/device cases. This consultation is free and confidential.

 

 

*This blog does not contain medical advice and is not intended to substitute for professional medical advice, diagnosis, or treatment.  Please consult with your physician for personalized medical advice.