More than 7,000 bottles of the antidepressant duloxetine have been recalled across the United States after they were found to contain levels of a potentially cancer-causing chemical above the limit set by the U.S. Food and Drug Administration (FDA).
The recall of Duloxetine Delayed-Release Capsules—manufactured by Towa Pharmaceutical Europe—was first initiated on Oct. 10 owing to a “nitrosamine drug substance related impurity,” according to an FDA notice.
The notice points to the presence of a chemical called N-nitroso-duloxetine that is above the agency’s “proposed interim limit.”
N-nitroso-duloxetine is toxic if swallowed and is suspected of causing cancer, according to the National Library of Medicine….