Recall D-0107-2025

US Class II Ongoing · initiated 2024-11-19

Recalling firm

Rising Pharma Holding, Inc., NJ

Product

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

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