DEFERASIROX Recall D-0095-2024
Description: Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
DEFERASIROX Recall D-0095-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0095-2024 |
| Event ID | 93219 |
| Brand | DEFERASIROX |
| Generic Name | DEFERASIROX |
| Manufacturer | DEFERASIROX |
| Original Package? | 1 |
| Active Substance | DEFERASIROX |
| Drug Route | ORAL |
| Distribution | USA nationwide |
| Quantity | 5,856 bottles |
| Recall Reason | Failed Dissolution Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20231115 |
| Product NDC | 68462-494 68462-495 68462-496 |
| Product NUI | N0000000144 N0000175522 N0000185506 |
| Pharma Class (EPC) | Iron Chelator [EPC] |
| Recall Initiation Date | 20231020 |
| Report Date | 20231115 |
| Classification Date | 20231108 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V8G4MOF2V9 |
| Drug Application Number | ANDA209433 |
| Structured Product Labeling (SPL ID) | 39df2882-2053-4c98-9a0b-80f71ec1306b |
| Structured Product Labeling (SPL Set ID) | 59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c |
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