Status
Ongoing
Drug Enforcement D-0190-2025
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Classification
Class II
Report Date
January 15, 2025
Termination Date
—
Product Information
- Product description
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Product quantity
- 244,460 bottles
- Reason for recall
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Rising Pharma Holding, Inc.
- Address
-
2 Tower Center Blvd Ste 1401
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0190-2025
- Event ID
- 96074
- Recall initiation date
- December 30, 2024
- Center classification date
- January 8, 2025
- Code info
- Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25
- More code info
- —