Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ

Recall Number: D-0106-2025

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 Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ