HYDROCHLOROTHIAZIDE Recall D-0894-2022
Description: Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
HYDROCHLOROTHIAZIDE Recall D-0894-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0894-2022 |
| Event ID | 90200 |
| Brand | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Generic Name | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Manufacturer | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Active Substance | HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM |
| Drug Route | ORAL |
| Distribution | FL |
| Quantity | 6 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . |
| Drug Classification | Class II |
| Drug Code Info | 20220601 |
| Product NDC | 72189-297 |
| Product NUI | N0000175359 N0000175419 M0471776 |
| Pharma Class (PE) | Increased Diuresis [PE] |
| Pharma Class (EPC) | Thiazide Diuretic [EPC] |
| Pharma Class (CS) | Thiazides [CS] |
| Recall Initiation Date | 20220511 |
| Report Date | 20220601 |
| Classification Date | 20220524 |
| Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
| Recalling Firm | Direct Rx |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0J48LPH2TH 3ST302B24A |
| Drug Application Number | ANDA202289 |
| Structured Product Labeling (SPL ID) | d2021060-94d8-3e1d-e053-2995a90a10ee |
| Structured Product Labeling (SPL Set ID) | d2021060-94d7-3e1d-e053-2995a90a10ee |
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