LOSARTAN POTASSIUM Recall D-0832-2022
Description: Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
LOSARTAN POTASSIUM Recall D-0832-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0832-2022 |
| Event ID | 90037 |
| Brand | LOSARTAN POTASSIUM |
| Generic Name | LOSARTAN POTASSIUM |
| Manufacturer | LOSARTAN POTASSIUM |
| Original Package? | 1 |
| Active Substance | LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide. |
| Quantity | 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220511 |
| Product NDC | 33342-044 33342-045 33342-046 |
| Drug UPC | 0333342045102 0333342046109 0333342045072 |
| Recall Initiation Date | 20220415 |
| Report Date | 20220511 |
| Classification Date | 20220503 |
| Address | 666 Plainsboro Rd Bldg 200 Ste 230 Plainsboro, NJ 08536-0009 United States |
| Recalling Firm | Macleods Pharma Usa Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3ST302B24A |
| Drug Application Number | ANDA202230 |
| Structured Product Labeling (SPL ID) | ed9b01e6-3ada-45f7-86ac-6361f9956326 |
| Structured Product Labeling (SPL Set ID) | 85d69d02-c5ef-467e-94aa-903100218795 |
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