Status
Ongoing
Drug Enforcement D-0162-2025
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Classification
Class II
Report Date
January 1, 2025
Termination Date
—
Product Information
- Product description
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Product quantity
- 76,968 bottles
- Reason for recall
- CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Address
-
15 Massirio Dr Ste 201
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0162-2025
- Event ID
- 95853
- Recall initiation date
- December 6, 2024
- Center classification date
- December 23, 2024
- Code info
- Lot # 230077C, exp. date 11/2025
- More code info
- —