Duloxetine Drug Recall: N-nitroso Impurity Exceeds FDA Limit
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules due to elevated N-nitroso-duloxetine impurity above FDA-recommended limits. Approximately 3,397 bottles were distributed nationwide.
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 with no reported illnesses or injuries. N-nitroso impurity represents a theoretical risk, consistent with the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg. The recalled product consists of 1,000-capsule bottles (approximately 3,397 bottles) that were distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the presence of N-nitroso-duloxetine impurity above the FDA-recommended limit.
The affected lots are #240947C and #240962C, both with an expiration date of 04/2027. The product carries NDC 82009-032-10 and was manufactured by Towa Pharmaceuticals Europe, S.L. in Barcelona, Spain, for Quallient Pharmaceuticals Health, LLC.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug
- Hazard
- n-nitroso-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 (3)
- Lot #: 240947C
- 240962C
- Exp. Date 04/2027
Distribution
Distributed nationwide across the United States.
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