Class IIReported 2025-01-01
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Recalled by PD-Rx Pharmaceuticals, Inc.
Reason for Recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
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Recall NumberD-0163-2025ClassificationClass IIStatusTerminatedCategorydrugInitiated2024-12-04Reported2025-01-01DistributionDistributed within US: FL, MS, WICode InfoLot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.