Breckenridge Pharmaceutical, Inc. is recalling 1,829 60-count bottles of Duloxetine Delayed-Release Capsules (60mg), a prescription medication used to treat depression, anxiety, and chronic pain. The recall was initiated because the product contains N-nitroso-duloxetine, an impurity found at levels higher than safety assessment limits. Consumers currently taking this medication should consult their doctor or pharmacist before stopping their treatment, as abruptly stopping some medications can cause health issues.
The impurity N-nitroso-duloxetine is a type of nitrosamine, which is classified as a probable human carcinogen. While nitrosamines are common in low levels in water and food, long-term exposure to levels above safety limits in medications may increase the risk of cancer over time.
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Manufactured by Towa Pharmaceutical Europe, S.L. in Spain; Distributed by Breckenridge Pharmaceuticals, Inc. Berkeley Heights, NJ.
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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