Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 10
Recalled December 11, 2024 · FDA recall D-0106-2025 · Rising Pharma Holding
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit · FDA Class II
Units
122,925 bottles
Sold at
Nationwide.
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
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
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →