Class II

Drug Recall: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

PD-Rx Pharmaceuticals, Inc. · December 4, 2024

Reason for Recall

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Distribution

Distributed within US: FL, MS, WI

States Affected

FL, MS, WI

Quantity Affected

70, 90-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0163-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

PD-Rx Pharmaceuticals, Inc. Drug Recall: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 | SafeCheck