Rising Pharma Holding, Inc. is recalling 360,667 bottles of Duloxetine Delayed-Release Capsules USP (the generic form of the medication Cymbalta) in 20 mg, 30 mg, and 60 mg strengths. The recall was initiated because testing found an impurity called N-nitroso-duloxetine at levels higher than the FDA's recommended safety limits, alongside other manufacturing deviations. These capsules were distributed nationwide in various bottle sizes, including 30-count, 60-count, and 1,000-count bottles.
The impurity N-nitroso-duloxetine belongs to a class of chemicals called nitrosamines, which are classified as probable human carcinogens. Long-term exposure to these impurities above safety limits may increase the risk of developing cancer.
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Distributed by Rising Pharm Holdings, Inc., East Brunswick, NJ
Distributed by Rising Pharm Holdings, Inc., East Brunswick, NJ
Distributed by Rising Pharm Holdings, Inc., East Brunswick, 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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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