Breckenridge Pharmaceutical, Inc. is recalling 14,863 bottles of Duloxetine Delayed-Release Capsules, USP (30 mg), a prescription medication used to treat depression and anxiety. The recall was issued because the capsules contain an impurity known as N-nitroso-duloxetine at levels higher than the FDA's recommended interim limit. This impurity belongs to a class of substances called nitrosamines, which may increase the risk of cancer if a person is exposed to them above acceptable levels over a long period of time.
The medication contains an impurity called N-nitroso-duloxetine that exceeds safety limits. Long-term exposure to this impurity is associated with a potential increased risk of cancer, though it does not pose an immediate acute health threat.
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Packaged in bottles of 1,000 capsules. Distributed by Breckenridge Pharmaceutical, Inc.
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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