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Popular antidepressant recalled for high levels of a potentially cancer-causing chemical
Breckenridge recalled nearly 360,000 bottles after testing found N-nitroso-duloxetine above the FDA’s recommended limit.
New Jersey-based Breckenridge Pharmaceutical recalled nearly 360,000 bottles of duloxetine, a generic version of Cymbalta, on June 4 after the FDA found levels of N-nitroso-duloxetine exceeded recommended limits.
According to the FDA, nitrosamines are compounds that can form during the manufacturing, storage, or packaging of medications and may increase cancer risks if patients are exposed above acceptable levels over long periods.
The recall affects 30-mg and 60-mg delayed-release capsules distributed nationwide, with affected 60-mg lots including 232311, 240317, and 240318, while 30-mg capsules carry lot code 241180C.
Health officials and experts advise patients not to stop taking the medication, which treats depression, anxiety, and fibromyalgia, without first speaking to a medical professional or pharmacist.
Recalls occur when manufacturers remove products that "present a risk of injury or gross deception or are otherwise defective," according to the FDA, which continues monitoring medication safety nationwide.