Class II
Ongoing
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
- Company
- Remedyrepack Inc.
- Recall Initiated
- December 2, 2024
- Posted
- January 1, 2025
- Recall Number
- D-0165-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 1,564 cards, b) 799 bottles
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Distribution
Nationwide in the US
Lot / Code Info
a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
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