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FDAFDA · Food and drugs·Recall number D-1161-2022

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

Published July 6, 2022 · Recall initiated: June 6, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
LOSARTAN POTASSIUM
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Distributor
Nationwide
UPC
0372789163901
Lot
Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22
Risk classification
Class II
Area (FDA)
drug
Country
United States

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