The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold.
The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder.
The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.
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