Hacked by Mr_Entity FDA requests voluntary recall of contaminated metformin products – Alla-Aamin Pharma
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FDA requests voluntary recall of contaminated metformin products

The FDA has asked five drug manufacturers to voluntarily recall several lots of extended-release metformin after agency lab testing revealed unacceptable levels of the nitrosamine impurity N-Nitrosodimethylamine, or NDMA.

On Oct. 9, 2020, the FDA provided an update to this recall to include two voluntary recalls by Marksans Pharma and Sun Pharmaceutical Industries for extended release metformin due to NDMA levels above the acceptable intake limit. This affects 76 additional lots of 500 mg and 750 mg of metformin ER tablets manufactured by Marksans and one lot of 500 mg per 5 mL of Riomet ER manufactured by Sun, according to the FDA.

In a press release, the agency stated it is in contact with five firms, which it did not name, to recommend they voluntarily recall their products and will post any recall notices on the FDA’s website. There are additional manufacturers of the metformin extended-release formulation that supply a substantial portion of the U.S. market, and their products are not being recalled, according to the FDA. The agency is working with those additional manufacturers to ensure appropriate testing, and assessments are underway to determine whether the recalls will result in shortages.

“We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in the release. “Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”

As Healio previously reported, the FDA announced in December that NDMA may be present in metformin based on reports from non-U.S. countries, which prompted an agency investigation. NDMA is naturally present in small amounts in food and water, such as cured and grilled meats, dairy products and vegetables, and the acceptable intake limit is 96 nanograms per day. The agency previously said that amounts above that limit may increase the risk for cancer.

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