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
Reported: July 6, 2022 Initiated: June 6, 2022 #D-1162-2022
Product Description
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
Details
- Recalling Firm
- PD-Rx Pharmaceuticals, Inc.
- Units Affected
- 687 bottles
- Distribution
- Nationwide
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 687 bottles.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2022. Severity: Moderate. Recall number: D-1162-2022.
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