Rising Pharma Holding, Inc. recalls Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57
Recalled December 11, 2024 · FDA recall D-0107-2025 · Rising Pharma Holding
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit · FDA Class II
Units
233,003 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), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →