More than 7,000 bottles of duloxetine, a generic version of antidepressant Cymbalta, have been recalled by the FDA due to the presence of N-nitroso-duloxetine, a chemical that is a suspected carcinogen.
The FDA's decision, issued Oct. 10, is a Class II recall, indicating that the affected drug could cause "temporary or medically reversible adverse health consequences." The recalled duloxetine had been distributed nationally by Towa Pharmaceutical Europe.
The FDA's recall involves 7,107 bottles containing 500 delayed-release 20 milligram duloxetine capsules, which are prescribed to treat conditions such as anxiety, depression, nerve pain related to diabetes, fibromyalgia and chronic pain associated with bones and muscles.
The affected lot number is 220128, with an expiration date of December 2024.