Recalls / Class II
Class IID-0562-2024
Product
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
- 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 #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
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, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 165,678, 90-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-05-17
- FDA classified
- 2024-06-20
- Posted by FDA
- 2024-06-26
- Terminated
- 2026-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0562-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.