Drug recall D-1162-2022
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
Lots and codes
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
Recall details
- Recalling firm
- PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
- Quantity
- 687 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 6, 2022
- Terminated
- June 17, 2024
Related products
- Losartan potassium – drug information
- NDC 72789-165 LOSARTAN POTASSIUM 100 mg · Losartan Potassium 100 mg/1 · PD-Rx Pharmaceuticals, Inc.
- NDC 72789-164 LOSARTAN POTASSIUM 50 mg · Losartan Potassium 50 mg/1 · PD-Rx Pharmaceuticals, Inc.
- NDC 72789-163 LOSARTAN POTASSIUM 25 mg · Losartan Potassium 25 mg/1 · PD-Rx Pharmaceuticals, Inc.