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 Comp

FDA recall notice · announced July 6, 2022 · Pd-rx Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lots: D21D63 Exp. 11/30/22; E21A73 Exp. 11/30/22; E21D35 Exp. 11/30/22; F21A28 Exp. 11/30/22; F21D04 Exp. 09/30/22; G21B03 Exp. 11/30/22; G21E23 Exp. 11/30/22; H21B46 Exp. 11/30/22; H21D46 Exp. 08/31/23; H21D46 Exp. 08/31/23; I21B67 Exp. 01/31/23; J21A26 Exp. 01/31/23; J21C44 Exp. 01/31/23
Quantity: 687 bottles
Status: Terminated
Products in this recall event:
- Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limite (D-1163-2022)
- 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, (D-1161-2022)
- 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, (D-1162-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.