Recalled Again? Diabetes Drug Metformin Possibly Contains Some Levels of Contamination

An additional drug for diabetes has been recalled, reportedly, for probable presence of contamination that exceeds the required daily limit.

According to reports on the issue, "The recall came from Nostrum Laboratories and followed an increasing number of similar recalls in the last couple of months.

Earlier this year the Food and Drug Administration had issued an editorial warning indicating that some lots of metformin extended-release medication contained some levels of NDMA or n-nitrosodimethylamine.

The recall of the new Metformin HCI Extended-Release Tablets comes from Kansas City-based Nostrum laboratories. The FDA underscored the said recall, which was said to be voluntary "and covers two lots of the medication" sold to consumers in 750-milligram strength.

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(Photo: Scott Olson/Getty Images)
Avkare and several other distributors are recalling the drug, which is used to treat people with type 2 diabetes, after high levels of N-nitrosodimethylamine (NDMA) impurities, a known carcinogen, have been found in the tablets.

The NMDA Contaminant

As with several other recalls this year, this particular recall is due to the potential presence of the environmental contaminant, NDMA, that's typically found in various food products, and water.

This impurity is quite difficult to avoid, although its status as a plausible human carcinogen means that the FDA has set a cap on how much consumers of NDMA can be exposed to at 96 ng each day.

In response to the recall, Nostrum Laboratories has advised its consumers who are currently in possession of the medications to return them to the drugstore from which they were bought.

As with the previous recalls, consumers are also advised to consult with their doctors about having their medication replaced instead of immediately stopping the intake of it. This is because of the risk of being unable to control blood sugar.

In May this year, the FDA released an advisory that alerted doctors and the public to the results of a test that found way too high NDMA levels in certain lots of metformin extended-release tablets.

At the same time, the FDA said it had been in contact with five other companies seeking voluntary recall of the medications.

According to Patrizia Cavazzoni, MD, the FDA Center for Drug Evaluation and Research acting director, now that they have determined some metformin products that failed to meet the standards, the agency is taking action.

"As we have been doing since this impurity was first identified," she also said, "We will communicate as new scientific information becomes available." Cavazzoni added, they are also taking action "if appropriate."

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Early Recalls

In mid-October, medical experts called out on those with diabetes and were taking a prescription drug to manage their blood glucose to contact their doctors.

Reports said, the call from the experts was due to commonly-taken medications for diabetes, popularly known as metformin, was reportedly being recalled due to potentially hazardous contamination the drug had.

In connection to the issue, the FDA announced in early October the most recent recall of metformin that time, because, the products manufactured by Marksans Pharma and Sun Pharmaceutical Industries potentially had cancer-causing agents called "nitrosamines."

Reports on the issue said the past recalls involved 500- and 700-milligram extended-release tablets. Furthermore, the FDA noted that the said immediate-release metformin did not seem to be contaminated.

Since December 2019, the FDA has been investigating further, metformin for its nitrosamine or carcinogenic agent content.

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