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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