Recall: D-1162-2022

Class II - Potentially Harmful

Class IIClassification

2022-06-06Initiated

TerminatedStatus

PD-Rx Pharmaceuticals, Inc.Firm

Product

Losartan Potassium Tablets, USP 50 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 72789-164-90 UPC 3 72789 16490 8

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.