Recalls / Class II
Class IID-0483-2024
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, 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
- 220456: Exp. Feb 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
- 7,188/ 500 count bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-04-29
- FDA classified
- 2024-05-04
- Posted by FDA
- 2024-05-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0483-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.