Duloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim 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 for manufacturing deviations involving N-nitroso impurities exceeding recommended limits. This constitutes a risk-of-harm product category with manufacturing contamination, but no illnesses or injuries have been reported, placing it in the High-severity tier per the rubric.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling 7,107 bottles of Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, due to Current Good Manufacturing Practice (CGMP) deviations related to the presence of N-nitroso-duloxetine impurity.
The recalled product is Duloxetine Delayed-Release Capsules, 20mg, distributed in 500-count bottles under NDC 51991-746-05, with Lot #220128 and expiration date 12/2024. The impurity level was found to exceed the FDA's recommended interim limit.
The product was distributed nationwide throughout the United States. The recall affects all patients who may have received bottles from this lot.
Patients should not discontinue their medication without consulting their healthcare provider. Those who have received this recalled lot should contact their pharmacy for a replacement or additional guidance.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Antidepressant
- Hazard
- nitrosamine-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 220128
- Exp. Date 12/2024
Distribution
Distributed nationwide across the United States.
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