The Food and Drug Administration (FDA) issued a Class II recall of more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a carcinogen.
Duloxetine belongs to a group of drugs called selective serotonin and norepinephrine reuptake inhibitors that are used to treat depression and anxiety, according to the Mayo Clinic.
A recall of the common antidepressant drug, also sold under the brand name Cymbalta, was first issued by the agency on Oct. 10.
The FDA noted that the drug had the “presence” of nitrosamine drug substance-related impurity above the acceptable intake limit.
Now, the FDA has downgraded the risk level associated with the drug recall to a Class II, which is issued when the use or exposure of a product “may cause temporary or medically reversible adverse health outcomes.”
Class II recalls are also issued when the likelihood of severe health outcomes from exposure or use of a product is “remote,” according to the agency’s website.
Nitrosamine impurities can increase the risk of cancer if “people are exposed to them above acceptable levels and over long periods of time,” according to the FDA.
The agency is specifically recalling 7,107 bottles of duloxetine delayed-release capsules manufactured by Towa Pharmaceutical Europe. The capsules are 20 milligram doses and come in bottles of 500 pills.
Neither Towa Pharmaceutical Europe nor its American subsidiary Breckenridge Pharmaceutical Inc have responded to requests for comment from The Hill.
Towa is working with the FDA and other regulators to implement the recall, the company wrote in an email to The Hill.
“As always, patient safety remains our top priority,” the company said.
At this time, Towa Pharmaceutical Europe is working with the FDA and other regulators to implement the recall.
People taking a prescription medication with potential nitrosamine impurities should stop taking the drug and speak with their health care provider about their concerns and other treatment options, per the FDA website.
