Metformin products recalled over NDMA excess levels

• The U.S. Food and Drug Administration announced this week that drug company Marksans Pharma Limited is recalling extended-release Metformin because the NDMA content in some lots was found to exceed the acceptable intake limit of 96 nanograms per day. 
• The recall also applies to 500 to 750 mg metformin tablets labeled Time-Cap Labs, Inc. 
• Metformin is widely used to treat type 2 diabetes by lowering blood glucose levels.

The U.S. Food and Drug Administration has announced the recall of certain Metformin hydrochloride products due to the diabetes drug possibly containing cancer-causing agents above the acceptable intake limit. 

Drugmaker Marksans Pharma Limited is voluntarily recalling extended-release (ER) metformin because it may have excess levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA), a likely human carcinogen. 

“Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day,” the FDA announced in a statement on Thursday.

Following a recall announced in June, Marksans scaled up this week’s voluntary recall by including 76 additional unexpired lots of metformin tablets between 500 mg and 750 mg, marketed under the brand name Time-Cap Labs, Inc. 

According to the FDA, the 500 mg tablets are stamped with “101” on one side while the 750 mg tablets come with “102” imprinted on one side. 

The FDA is currently investigating the source of the NDMA and how it ended up in metformin products. While most levels are generally found in medicines within the FDA’s accepted daily intake, the recently recalled drugs are higher than that. 

Metformin (ER) is used to reduce blood glucose levels in type 2 diabetes. Patients taking this drug are advised to continue taking it until they consult with their doctors.

“It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” warned the FDA. 

The FDA also advises users to contact their physician or healthcare provider immediately if they have experienced unfavorable reactions that may be related to their use of the drug.

Source: New York Post