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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0095-2024
Event ID93219
Original Package?1
Active SubstanceDEFERASIROX
Drug RouteORAL
DistributionUSA nationwide
Quantity5,856 bottles
Recall ReasonFailed Dissolution Specifications
Drug ClassificationClass II
Drug Code Info20231115
Product NDC68462-494 68462-495 68462-496
Product NUIN0000000144 N0000175522 N0000185506
Pharma Class (EPC)Iron Chelator [EPC]
Recall Initiation Date20231020
Report Date20231115
Classification Date20231108
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient IdentifierV8G4MOF2V9
Drug Application NumberANDA209433
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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