Drug recall D-0165-2025

Class II Ongoing reported Jan 1, 2025

Product

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.

Lots and codes

a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025

Recall details

Recalling firm
RemedyRepack Inc., Indiana, PA
Quantity
a) 1,564 cards, b) 799 bottles
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
December 2, 2024