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TGA Action ID	RC-2023-RN-00532-1
Type of Product	Medicine
Product Name/Description	FLUOROURACIL 3,675MG IN 0.9% SODIUM CHLORIDE IN SUREFUSER + (5ML/HR) FOR INTRAVENOUS INFUSION. Batch Number: BB2306947 Product is exempt from the ARTG
ARTG Number
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	A batch (BB2306947) of FLUOROURACIL 3,675MG IN 0.9% SODIUM CHLORIDE IN SUREFUSER + (5ML/HR) FOR INTRAVENOUS INFUSION) was identified to have been incorrectly compounded. Slade Health has internally identified that the affected product, which was labelled to contain 3,675 mg of Fluorouracil, actually contained a drug content 4.8% higher than the labelled dose.
Instructions for Customers/Users	Customers should discard the product at customer site. This action has been closed out on 27/10/2023
Action Commencement Date	14/06/2023
Responsible Entity	Slade Health Pty Ltd
Contact Information	03 9565 4400 - Slade