Class IIReported 2025-01-15
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Recalled by Rising Pharma Holding, Inc.
Reason for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Advertisement
Recall NumberD-0188-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-12-30Reported2025-01-15DistributionNationwideCode Infoa) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.