Recalls / Class II
Class IID-0482-2024
Product
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- 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
- 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: 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
- 281,554/90 & 1000 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-0482-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.