Recalls / Class II
Class IID-0009-2025
Product
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 51991-746, 51991-747, 51991-748, 51991-750
- FDA application
- ANDA203088
- Affected lot / code info
- Lot #: 220128, Exp. Date 12/2024
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 7,107 bottles
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2024-10-10
- FDA classified
- 2024-10-11
- Posted by FDA
- 2024-10-23
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.