Product Safety Recalls

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RUFINAMIDE Recall D-1088-2023

Description: Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08

RUFINAMIDE Recall D-1088-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1088-2023
Event ID92756
Original Package?1
Active SubstanceRUFINAMIDE
Drug RouteORAL
DistributionUSA nationwide
Quantity48 bottles
Recall ReasoncGMP deviations: Batch was released prior to approval.
Drug ClassificationClass II
Drug Code Info20230830
Product NDC59651-616 59651-617
Drug UPC0359651616086
Recall Initiation Date20230721
Report Date20230830
Classification Date20230818
Address279 Princeton Hightstown Rd
East Windsor, NJ 08520-1401
United States
Recalling FirmAurobindo Pharma USA Inc.
Initial Notification Letter
Unique Ingredient IdentifierWFW942PR79
Drug Application NumberANDA217230
Structured Product Labeling (SPL ID)d9ffc833-d902-41cb-8e8e-6bbba8e65b9e
Structured Product Labeling (SPL Set ID)d9ffc833-d902-41cb-8e8e-6bbba8e65b9e
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