Recall D-0165-2025

US Class II Ongoing · initiated 2024-12-02

Recalling firm

RemedyRepack Inc., PA

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.

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