Breckenridge Pharmaceutical, Inc. is recalling 3,591 bottles of Duloxetine Delayed-Release Capsules (30 mg), a prescription medication used to treat depression and anxiety. The recall was initiated because testing found levels of an impurity called N-nitroso-duloxetine that exceed the FDA's proposed safety limits. This medication was manufactured by Towa Pharmaceutical Europe and distributed under the Quallent Pharmaceuticals brand.
The product contains N-nitroso-duloxetine at levels above the interim safety limit; nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
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Manufactured by Towa Pharmaceutical Europe, S.L.
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Sources: FDA iRES · Raw API Response
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