ESTRADIOL Recall D-0543-2024
Description: Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
ESTRADIOL Recall D-0543-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0543-2024 |
| Event ID | 94649 |
| Brand | ESTRADIOL |
| Generic Name | ESTRADIOL |
| Manufacturer | ESTRADIOL |
| Original Package? | 1 |
| Active Substance | ESTRADIOL |
| Drug Route | TRANSDERMAL |
| Distribution | Nationwide within the United States |
| Quantity | 13,440 units |
| Recall Reason | Failed Impurities/Degradation Specifications. |
| Drug Classification | Class III |
| Drug Code Info | 20240612 |
| Product NDC | 70710-1191 70710-1192 70710-1193 |
| Product NUI | M0447348 N0000175825 N0000000100 |
| Drug UPC | 0370710119188 0370710119485 0370710119287 |
| Pharma Class (EPC) | Estrogen [EPC] |
| Pharma Class (CS) | Estradiol Congeners [CS] |
| Recall Initiation Date | 20240516 |
| Report Date | 20240612 |
| Classification Date | 20240606 |
| Address | 73 Route 31 NN/A Pennington, NJ 08534-3601 United States |
| Recalling Firm | Zydus Pharmaceuticals (USA) Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4TI98Z838E |
| Drug Application Number | ANDA206241 |
| Structured Product Labeling (SPL ID) | 51a2adf6-a381-42cb-bf3e-8c83a7cfe738 |
| Structured Product Labeling (SPL Set ID) | 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f |
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