LOSARTAN POTASSIUM Recall D-0788-2022
Description: Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.
LOSARTAN POTASSIUM Recall D-0788-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0788-2022 |
| Event ID | 89968 |
| Brand | LOSARTAN POTASSIUM |
| Generic Name | LOSARTAN POTASSIUM |
| Manufacturer | LOSARTAN POTASSIUM |
| Active Substance | LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | Product was distributed to customers in AK and PA. |
| Quantity | 433/30 count blister cards, 33/60 count blister cards |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. |
| Drug Classification | Class II |
| Drug Code Info | 20220504 |
| Product NDC | 70518-3282 |
| Recall Initiation Date | 20220406 |
| Report Date | 20220504 |
| Classification Date | 20220426 |
| Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
| Recalling Firm | RemedyRepack Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | 3ST302B24A |
| Drug Application Number | ANDA078232 |
| Structured Product Labeling (SPL ID) | d395b63e-8855-7da7-e053-2a95a90a1e00 |
| Structured Product Labeling (SPL Set ID) | c43e9dc6-2c8a-47d7-b40d-eb55dfe11a51 |
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