PD-Rx Pharmaceuticals, Inc.: Drug Recall

Recall #D-0557-2023 · 04/06/2023

Class II: Risk

Recall Details

Recall Number: D-0557-2023
Classification: Class II
Product Type: Drug
Recalling Firm: PD-Rx Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 04/06/2023
Location: Oklahoma City, OK, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 352 bottles

Reason for Recall

CGMP deviations.

Product Description

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

Distribution Pattern

Nationwide in the US.

Other Recalls by PD-Rx Pharmaceuticals, Inc.

Class II: Risk 12/04/2024

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Class II: Risk 04/06/2023

CGMP deviations.
Class II: Risk 04/06/2023

CGMP deviations.
Class II: Risk 04/06/2023

CGMP deviations.
Class II: Risk 04/06/2023

CGMP deviations.

View all recalls by PD-Rx Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.