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

Recall Number: D-0107-2025

Firm: Rising Pharma Holding, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20241211

Initiation Date: 20241119

Termination Date:

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

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