Breckenridge Pharmaceutical, Inc. has voluntarily recalled 7,107 bottles of Duloxetine Delayed-Release Capsules (20mg), a generic 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 recommended safety limits. This specific recall affects 500-count bottles labeled with NDC 51991-746-05 and lot number 220128.
The product contains N-nitroso-duloxetine, a type of nitrosamine. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure to levels above safety limits may potentially increase the risk of cancer.
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Distributed by: BPI; Manufactured by: Towa Pharmaceutical Europe, S.L.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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