Class IIReported 2025-03-26
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Recalled by Rising Pharma Holding, Inc.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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Recall NumberD-0277-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-03-05Reported2025-03-26DistributionNationwide in the USA.Code InfoLot #: DTB23111A, Exp 8/31/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.