Prescription Duloxetine 60 mg capsules recalled for N-nitroso impurity
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving N-nitroso-duloxetine, a known genotoxic impurity, found above the FDA's recommended interim limit. No illnesses or injuries reported in the source, but the presence of this impurity above regulatory thresholds constitutes a risk-of-harm scenario.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg in 90-count bottles. The recall is due to a CGMP deviation that resulted in the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. The product was manufactured by Towa Pharmaceutical Europe, S.L. in Spain.
N-nitroso-duloxetine is an impurity that can form during the manufacturing process. Testing identified levels of this impurity exceeding the FDA's recommended safety threshold. N-nitroso compounds are of regulatory concern due to their potential health risks.
The product was distributed nationwide in the United States. Affected lots include: 230028C (expires Nov 2025), 230106C (expires Dec 2025), 230170C (expires Dec 2025), 220039 (expires Dec 2024), and 220363 (expires Feb 2025). Approximately 281,554 bottles were distributed. Patients taking this medication should contact their healthcare provider to discuss alternative treatment options. The product should be returned to the pharmacy where it was obtained.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Prescription Drug
- Hazard
- nitroso-impurity
Distribution
Distributed nationwide across the United States.
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