Product Safety Recalls

Product Recall Tracker

DEXAMETHASONE Recall D-0995-2022

Description: TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01

DEXAMETHASONE Recall D-0995-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0995-2022
Event ID89646
BrandTOBRADEX
Generic NameTOBRAMYCIN AND DEXAMETHASONE
ManufacturerTOBRAMYCIN AND DEXAMETHASONE
Original Package?1
Active SubstanceDEXAMETHASONE TOBRAMYCIN
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity3 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0078-0876
Product NUIN0000175576 N0000175450 N0000175477
Pharma Class (EPC)Corticosteroid [EPC]
Pharma Class (CS)Aminoglycosides [CS]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier7S5I7G3JQL VZ8RRZ51VK
Drug Application NumberNDA050616
Structured Product Labeling (SPL ID)d8137608-cc62-41a5-9d33-18df480e4152
Structured Product Labeling (SPL Set ID)7f310e0e-0d3b-493d-b6c4-238493a2a9b9
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