HYDROCHLOROTHIAZIDE Recall D-0971-2022
Description: Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
HYDROCHLOROTHIAZIDE Recall D-0971-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0971-2022 |
| Event ID | 90161 |
| 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 | AL, GA, FL, LA |
| Quantity | 81 bottles |
| Recall Reason | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| Drug Classification | Class II |
| Drug Code Info | 20220608 |
| Product NDC | 72189-012 72189-098 72189-129 |
| 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 | 20220505 |
| Report Date | 20220608 |
| Classification Date | 20220527 |
| 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 | ANDA091629 |
| Structured Product Labeling (SPL ID) | cf41f400-4188-72ca-e053-2995a90a6142 |
| Structured Product Labeling (SPL Set ID) | 8de04bf2-83dd-c494-e053-2a95a90abade |
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