PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 6, 2022 Initiated: June 6, 2022 #D-1161-2022

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

Reason for Recall

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

Details

Units Affected
1441 bottles
Distribution
Nationwide
Location
Oklahoma City, OK

Frequently Asked Questions

What product was recalled?
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. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 1441 bottles.
Why was this product recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall?
This recall was issued by the FDA Drug on July 6, 2022. Severity: Moderate. Recall number: D-1161-2022.