D-0165-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2025
- Initiation Date
- December 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1,564 cards, b) 799 bottles
Product Description
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Distribution Pattern
Nationwide in the US
Code Information
a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025