The U.S. Food and Drug Administration (FDA) has recalled thousands of bottles of an antidepressant drug after discovering traces of a cancer-causing chemical.

The agency issued a Class II recall on approximately 7,100 bottles of duloxetine.

Duloxetine is sold under the brand name Cymbalta.

From The Washington Times:

In the recall notice, the FDA said the agency found traces of a nitrosamine, or carcinogenic, substance in bottles of duloxetine above the legal limit.

“If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer,” the FDA said in its notice. “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”

The recall is listed as a Class II recall by the FDA, meaning that exposure to the recalled drugs could cause temporary or reversible health consequences. The recall affects over 7,000 bottles of the medication.

The two most popular name-brand medications that use duloxetine are Cymbalta and Yentreve. The drugs are used to treat nerve pain, anxiety, depression and incontinence.

The FDA urged patients who think their medication could fall under the recall to contact their pharmacy for further information.

The Hill reports:

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.

 

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