FDA recall D-0190-2025

Rising Pharma Holding, Inc. · Class II · drug

Product

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm 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: 2024-12-30
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0190-2025