Rising Pharma Holding, Inc. recalls Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distribu
Recalled January 15, 2025 · FDA recall D-0190-2025 · Rising Pharma Holding
Hazard
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. · FDA Class II
Units
244,460 bottles
Sold at
Nationwide
Description
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →