PD-Rx Pharmaceuticals, Inc.: Drug Recall

Recall #D-1161-2022 · 06/06/2022

Class II: Risk

Recall Details

Recall Number: D-1161-2022
Classification: Class II
Product Type: Drug
Recalling Firm: PD-Rx Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 06/06/2022
Location: Oklahoma City, OK, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1441 bottles

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Product Description

Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1

Distribution Pattern

Nationwide

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.