A recall has been ordered for a high-profile diabetes drug after producers discovered it contained alarmingly high levels of a cancer-causing impurity.
Marksans Pharma Limited has recalled metformin hydrochloride extended-release tablets due to their excessive levels of NDMA, a “probable human carcinogen,” noted the Food and Drug Administration in a press release.
The amount of NDMA in the tablets exceeded the acceptable daily intake limit of 96 nanograms per day, according to the FDA.
The Food and Drug Administration has recalled a diabetes drug. (Jacquelyn Martin/)
Metformin tablets are used to decrease glucose levels and treat type 2 diabetes.
The recall applies to metformin tablets ranging between 500 milligrams and 750 milligrams, which are sold under the brand name Time-Cap Labs, Inc., reported CNN Health.
“NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables,” read an FDA statement. “Markans Pharma Limited has not received any reports of adverse events that have been related to this recall.”
Metformin tablets are used to decrease glucose levels and treat type 2 diabetes. The recall is a broadening of a prior retraction of the same product from the summer.
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Seven other pharmaceutical manufacturers have issued recalls for metformin hydrochloride extended-release tablets due to their potential cancer-causing contents.
The FDA is still investigating where NDMA comes from and how it ends up in metformin products. Most levels found in medications are generally low and fall within the FDA’s accepted daily intake, but recently recalled medications exceed that amount, noted CNN.
Marksans did not reveal how much NDMA is in their recalled products.