Product Safety Recalls

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BUDESONIDE Recall D-0275-2024

Description: Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

BUDESONIDE Recall D-0275-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0275-2024
Event ID93740
Original Package?1
Active SubstanceBUDESONIDE
Drug RouteORAL
Quantity10,672 30-count bottles
Recall ReasonFailed Dissolution Specifications
Drug ClassificationClass II
Drug Code Info20240207
Product NDC0591-2510
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20240108
Report Date20240207
Classification Date20240126
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA, Inc
Initial Notification Letter
Unique Ingredient IdentifierQ3OKS62Q6X
Drug Application NumberANDA205457
Structured Product Labeling (SPL ID)29146990-42bc-43d6-8b61-717df1c7e054
Structured Product Labeling (SPL Set ID)41d4fd39-81ee-41be-b34d-efb12b3a359d
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