The drug may contain unsafe levels of a cancer causing element called N-Nitrosodimethylamine.
If you take a diabetes drug called Metformin, grab your prescription bottle. The U.S. Food and Drug Administration has issued a recall for Metformin made by Marksans Pharma Limited and Sun Pharmaceuticals because the drug could contain unacceptable levels of a cancer-causing chemical. The recall includes different dosages and lots under the names Time-Cap Labs and Riomet ER. Issued on October 5, 2020, the recall is a part of a larger recall issued on June 5, 2020. Metformin is a drug that helps stabilize blood sugar levels in patients with diabetes. No problems with these drugs have been reported at this time.
The drugs may contain unacceptable levels of a contaminant called N-Nitrosodimethylamine,(NDMA) found in water, dairy products, meat, and produce. The substance could cause cancer in people ingesting more than 96mg per day. The recall impacts the following 500 mg and 700 mg extended release tablets made by Marksans Pharma Limited and Sun Pharmaceuticals:
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg:
100 counts: 49483-624-01
A list of the corresponding lot numbers can be found here.
Anyone taking this drug should return it to the pharmacy where it was purchased for a replacement. You should not stop taking the drug until you can get a replacement without taking to a doctor or healthcare professional. Stopping the drug could be dangerous for people suffering from Type 2 diabetes.
If you think you have experienced any adverse affects from this drug, contact your doctor and file a report with the FDA’s MedWatch Adverse Event Reporting program. You can fill out a report online or request a form by calling 1-800-332-1088.