Home / Recalls / PD-Rx Pharmaceuticals, Inc. / D-0163-2025

D-0163-2025 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
January 1, 2025
Initiation Date
December 4, 2024
Termination Date
March 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70, 90-count bottles

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

Distribution Pattern

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

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  • D-0059-2021 Class II — metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 727 (October 6, 2020)