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TGA Action ID
RC-2026-RN-00574-1
Type of Product
Medicine
Product Name/Description
OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial
Batch number: 25ZF0500, 24ZF030B03, 24ZF025E01, 24ZF025D01, 24ZF017A05
Expiry Date: 09-2028, 05-2027, 04-2027, 04-2027, 03-2027
ARTG Number
47998
Action Type
Product Correction
Action Level
Hospital
Hazard Classification
Class III
Reason for the Action
The vial label of some batches of Optiray 350 100 mL vials is incorrect. It lists the ingredients' quantities for Optiray 350 75 mL vial instead.
The ingredients' quantities listed on the product carton are accurate.
Instructions for Customers/Users
Customers are to:
- Refer to the product carton for the correct ingredients' quantities.
- Continue to administer the product in accordance with the Product Information (PI).
Action Commencement Date
3/08/2026
Responsible Entity
Guerbet Australia Pty Ltd
Contact Information
1800 859 436 - Customer Service