Breckenridge Pharmaceutical, Inc. is recalling approximately 36,974 bottles of Duloxetine Delayed-Release Capsules, USP (available in 20mg, 30mg, and 60mg strengths) due to the presence of a chemical impurity called N-nitroso-duloxetine. Testing discovered that the levels of this impurity were above the FDA's recommended interim safety limits. The affected medication was manufactured by Towa Pharmaceutical Europe in Spain and distributed nationwide in 500-count and 1,000-count bottles.
N-nitroso-duloxetine is a nitrosamine impurity. Nitrosamines are classified as probable human carcinogens, and long-term exposure to levels above the recommended safety limit may increase the risk of cancer.
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Mfr. by: Towa Pharmaceutical Europe, S.L.
Mfr. by: Towa Pharmaceutical Europe, S.L.
Mfr. by: Towa Pharmaceutical Europe, S.L.
Image 1: Label for 250 mL Excel Bag containing PHENYLephrine 40 mg added to 0.9% Sodium Chloride
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 · FDA Press Release · Raw API Response
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