Status
Ongoing
Drug Enforcement D-0107-2025
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Classification
Class II
Report Date
December 11, 2024
Termination Date
—
Product Information
- Product description
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
- Product quantity
- 233,003 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-0107-2025
- Event ID
- 95756
- Recall initiation date
- November 19, 2024
- Center classification date
- December 5, 2024
- Code info
- a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25
- More code info
- —