FDAHealthDecember 4, 2024

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

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

Is this relevant to me?

Geography: US, FL, MS, WI
Source agency: FDA
Category: Health
Published: December 4, 2024

Distributed within US: FL, MS, WI

What's affected?

Product: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Brand: PD-Rx Pharmaceuticals, Inc.
Lot code: I24E77

Additional details

Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 70, 90-count bottles.

View original FDA notice →

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