Class IIReported 2025-01-01

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.

Recall Number

D-0165-2025

Classification

Class II

Status

Ongoing