Duloxetine Capsules Recalled for N-Nitroso Impurity Exceeding FDA Limits
Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.
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 drug recall with a detected high-risk pharmaceutical impurity (N-nitroso-duloxetine) above recommended limits, but with no reported illnesses or injuries. Score follows the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine delayed-release capsules, 20 mg (NDC 51991-746-05), due to the presence of N-nitroso-duloxetine impurity above FDA-recommended interim limits. This impurity was detected as part of a current Good Manufacturing Practice (cGMP) deviation.
The recall encompasses approximately 11,125 bottles with lot number 240098C and an expiration date of January 2027. The affected capsules were manufactured by Towa Pharmaceutical Europe, S.L. in Martorelles, Barcelona, Spain, and distributed nationwide by Breckenridge Pharmaceutical in Berkeley Heights, New Jersey.
Consumers with this specific lot should contact their pharmacy or healthcare provider for guidance regarding this recall.
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 (2)
- Lot#: 240098C
- Expiration: 01/2027.
Distribution
Distributed nationwide across the United States.
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