Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
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: This FDA Class II recall involves N-nitroso-duloxetine, a chemical impurity, exceeding the FDA's recommended interim limit due to a CGMP deviation. No adverse events or illnesses have been reported in the source material, making this a risk-of-harm scenario without confirmed patient injury, which per the rubric warrants a High severity score of 3.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Hydrochloride delayed-release capsules, 30mg strength, distributed nationwide. The capsules are available in 90-count and 1000-count bottles (NDC 51991-747-90 and NDC 51991-747-10).
The recall is due to the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. The impurity was identified during manufacturing quality testing, indicating a Current Good Manufacturing Practice (CGMP) deviation at the manufacturing facility.
Affected lots include bottles with the following codes and expiration dates: 220265 (Exp. Feb 2025), 220088 (Exp. Nov 2024), 220267 (Exp. Feb 2025), 220256 (Exp. Feb 2025), 220225 (Exp. Jan 2025), and 220269 (Exp. Feb 2025). Approximately 281,554 units have been distributed nationwide.
Patients taking this medication should contact their healthcare provider or pharmacy to discuss whether they may have received affected bottles. Healthcare providers should consult the FDA recall notice for detailed lot codes and disposition instructions.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Prescription Drug
- Hazard
- n-nitroso-impurity
- chemical-contamination
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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