FDA recall D-0106-2025

Rising Pharma Holding, Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-11-19
Report date: 2024-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0106-2025