LOSARTAN POTASSIUM Recall D-1163-2022
Description: 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
LOSARTAN POTASSIUM Recall D-1163-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1163-2022 |
| Event ID | 90383 |
| Brand | LOSARTAN POTASSIUM |
| Generic Name | LOSARTAN POTASSIUM |
| Manufacturer | LOSARTAN POTASSIUM |
| Active Substance | LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 1320 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220706 |
| Product NDC | 72789-163 72789-164 72789-165 |
| Drug UPC | 0372789163901 0372789164908 0372789165905 |
| Recall Initiation Date | 20220606 |
| Report Date | 20220706 |
| Classification Date | 20220627 |
| Address | 727 N Ann Arbor Ave Oklahoma City, OK 73127-5822 United States |
| Recalling Firm | PD-Rx Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3ST302B24A |
| Drug Application Number | ANDA090382 |
| Structured Product Labeling (SPL ID) | d57ec0fb-1969-1d80-e053-2995a90a4e48 |
| Structured Product Labeling (SPL Set ID) | 372ba4ad-26ca-4675-8475-4b664fbecba9 |
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