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DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklah...

FDA Recall #D-0163-2025 — Class II — December 4, 2024

Recall #D-0163-2025 Date: December 4, 2024 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

PD-Rx Pharmaceuticals, Inc. — Oklahoma City, OK

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

70, 90-count bottles

Distribution

Distributed within US: FL, MS, WI

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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