More than 14,700 bottles of Duloxetine — commonly prescribed for individuals with depression and anxiety conditions — were recalled nationwide after the antidepressant was found to contain N-nitroso-duloxetine impurity above the FDA’s recommended interim limit.
Breckenridge Pharmaceutical initiated a voluntary recall of 14,729 bottles of Duloxetine delayed-release capsules, USP, 30 milligrams, June 4. The recall affects Duloxetine capsules packaged in 1,000-capule bottles, manufactured by Towa Pharmaceutical Europe in Spain and distributed by Breckenridge Pharmaceuticals. The FDA classified the action as a Class II recall June 8, according to its website.
Exposure to nitrosamine impurities above acceptable levels over long periods may increase cancer risk, according to the FDA. An individual taking a drug containing nitrosamine at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer. N-nitroso-duloxetine is a type of nitrosamine.
A Class II recall involves products that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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