Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Recall Number: D-0105-2025

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, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60