Breckenridge Pharmaceutical, Inc. is recalling 1,856 bottles of Duloxetine Delayed-Release Capsules (60 mg) because testing found levels of an impurity above FDA limits. The affected medication was manufactured by Towa Pharmaceutical Europe and sold in 1,000-count bottles under the Quallent Pharmaceuticals Health LLC label. If you are taking this medication, do not stop taking it without first talking to your doctor or pharmacist, as the risks of stopping suddenly may outweigh the risk of the impurity.
The product contains N-nitroso-duloxetine, a nitrosamine impurity. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure to levels above recommended limits may increase the risk of developing cancer.
You have 2 options:
Manufactured by Towa Pharmaceutical Europe, S.L. for Quallent Pharmaceuticals Health LLC.
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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