FDAFDA · Food and drugs·Recall number D-0163-2025
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Published January 1, 2025 · Recall initiated: December 4, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Distributor
- Distributed within US: FL, MS, WI
- Lot
- Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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