NEW YORK (WPIX) – A pharmaceutical company issued a recall this month for thousands of bottles of duloxetine, a medicine often prescribed to treat depression.
Over 7,100 bottles of duloxetine delayed-release capsules were recalled due to the elevated presence of nitrosamines, an ingredient believed to be cancerous, according to the FDA. Nitrosamines are already present “in low levels in our water and foods,” the agency explains, but can also form during chemical reactions during the drug-manufacturing process.
“Some nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the FDA explains. “People taking drugs that contain NDMA at or below the acceptable intake limits every day for 70 years are not expected to have an increased risk of cancer.”
The agency labeled the recall as a Class II, meaning the product has a low chance of causing significant injuries or death.
The recalled duloxetine capsules were manufactured by Towa Pharmaceutical Europe and distributed nationally by Breckenridge Pharmaceutical, Inc., of Connecticut, according to a recall notice. They were prescribed in 20mg delayed-release capsules, in 500-count bottles.
Duloxetine may also be recognized by other brand names, including Cymbalta, Drizalma Sprinkle and Irenka, per the Mayo Clinic. Duloxetine may be prescribed as an antidepressant, but also to treat anxiety or “pain caused by nerve damage associated with diabetes,” according to the organization.