Duloxetine Recall: FDA Sets Second-Highest Risk Level for Antidepressants Containing Potential Carcinogen

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Duloxetine Recall: FDA Sets Second-Highest Risk Level for Antidepressants Containing Potential Carcinogen
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Certain bottles and doses of duloxetine, a common antidepressant, have been recalled due to the presence of potentially cancer-causing chemicals. The recall was initiated on Nov. 19 by manufacturer Rising Pharma, Inc. and was set as a 'class II' risk level by the FDA on Dec. 5.

Korin Miller is a health and lifestyle journalist who has been published in The Washington Post, Prevention, SELF, Women's Health, The Bump, and Yahoo, among other outlets.Nick Blackmer is a librarian, fact-checker, and researcher with more than 20 years of experience in consumer-facing health and wellness content.Certain bottles and doses of duloxetine, a common antidepressant, have been recalled due to the presence of potentially cancer-causing chemicals.

The medication was recalled due to the "presence of N-nitroso-duloxetine impurity above recommended interim limit," the FDA said. On Nov. 19, various doses of duloxetine delayed-release capsules manufactured by Rising Pharma, Inc., were recalled due to the "presence of N-nitroso-duloxetine impurity above recommended interim limit," the FDA said in three separate enforcement reports.

Duloxetine—the generic version of drugs sold under the brand names Cymbalta and Irenka—is used to treat depression in adults andA class II recall is the FDA’s second most serious recall status. It’s given to a product when its use “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”The new duloxetine recall affects various doses and bottles of the medication.

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