ESTRADIOL Recall D-0180-2024
Description: ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
ESTRADIOL Recall D-0180-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0180-2024 |
| Event ID | 89450 |
| Brand | ESTRADIOL |
| Generic Name | ESTRADIOL |
| Manufacturer | ESTRADIOL |
| Original Package? | 1 |
| Active Substance | ESTRADIOL |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 0555-0886 0555-0899 0555-0887 |
| Product NUI | M0447348 N0000175825 N0000000100 |
| Pharma Class (EPC) | Estrogen [EPC] |
| Pharma Class (CS) | Estradiol Congeners [CS] |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4TI98Z838E |
| Drug Application Number | ANDA040197 |
| Structured Product Labeling (SPL ID) | 80d8c060-3bbd-4010-9402-b191ec10717e |
| Structured Product Labeling (SPL Set ID) | c4936878-1643-4e7f-9b0d-e4957935aef2 |
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