Drug recall D-1163-2022
Product
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 Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
Lots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 10/31/22; K21A61 Exp. 11/30/22; L21A45 Exp. 11/30/22
Recall details
- Recalling firm
- PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
- Quantity
- 1320 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.