A second, expanded nationwide recall has been issued for a popular antidepressant after it was found to contain a potentially cancer-causing chemical.
The recall affects over 233,000 bottles of duloxetine, the generic form of Cymbalta and Irenka. This medication is prescribed for the treatment of depression and generalized anxiety disorder, as well as pain associated with fibromyalgia and nerve damage from diabetes.
New Jersey-based Rising Pharmaceuticals initially recalled the drugs on November 19. The U.S. Food and Drug Administration updated the recall on December 5 to classify the drugs as a Class II risk. It's the agency's second-most extreme risk level, assigned when a product may cause "medically reversible adverse health consequences."
According to the FDA's Enforcement Report, various doses of duloxetine delayed-release capsules may contain the "presence of N-nitroso-duloxetine impurity above recommended interim limit."
N-nitroso-duloxetine is a type of nitrosamine, a class of substances known to be carcinogenic when ingested in certain amounts over time.
The recall includes Duloxetine Delayed-Release Capsules (60 mg) sold in 30 count, 90 count and 1,000 count bottles.
In October, a separate, smaller nationwide recall of duloxetine was initiated by a different company for the same reason. Connecticut-based Breckenridge Pharmaceutical, Inc. recalled 7,107 bottles of duloxetine that were manufactured by Towa Pharmaceutical Europe, due to the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
That recall included Duloxetine Delayed-Release Capsules (20 mg) sold in 500 count bottles.
Anyone with the recalled drugs should stop taking them and talk to their health care provider about alternative treatment options.