D-0190-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2025
- Initiation Date
- December 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 244,460 bottles
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
Reason for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Distribution Pattern
Nationwide
Code Information
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