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Antidepressant Recall Update As FDA Sets Risk Level [Video]

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New Brunswick News

A commonly prescribed antidepressant has been recalled across the U.S. due to fears of contamination with a potentially cancer-causing chemical.

233,003 bottles of the drug, named Duloxetine, were voluntarily recalled by their distributor, Rising Pharmaceuticals, Inc.—based in East Brunswick, New Jersey—on November 19.

The recall was voluntarily initiated by the firm due to the “presence of N-nitroso-duloxetine impurity above recommended interim limit.”

The recalled drugs have now been issued a “Class II” risk level by the U.S. Food and Drug Administration (FDA).

Stock image of medication. A brand of antidepressant has been recalled due to potential contamination with cancer-causing chemical impurities.ISTOCK / GETTY IMAGES PLUS

A Class II recall is the second-most extreme, and is given when “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA.

Duloxetine is a prescription medication …

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