Fludeoxyglucose (18F) Injection (FDG)
OFFICIAL-SOURCE RECALL · AUSTRALIA
Fludeoxyglucose (18F) Injection (FDG) Recall: Classification Class II Reason for the Action
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryAustraliaPublishedJuly 27, 2026Last updatedJuly 27, 2026Official source last checkedAugust 14, 2026 at 7:44 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Fludeoxyglucose (18F) Injection (FDG)
- Manufacturer
- See official notice
- Lot number
- numbers, 6210-067
- Batch number
- numbers, 6210-067
- Date code
- dates, 27/07/2026
- Expiration date
- dates, 27/07/2026
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class II Reason for the Action Cyclotek was notified of a defective product (cracked vial), that was supplied to a customer site on 27 July 2026. The defect was identified upon receipt and was returned to the manufacturing facility. A new vial was supplied. Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). Instructions for Customers/Users Product was not used and was returned to Cyclotek as soon as possible. New vial dispensed and sent to customer to cover patient doses. Action Commencement Date 29/07/2026 Responsible Entity Cyclotek NSW Pty Ltd
Hazard
Classification Class II Reason for the Action Cyclotek was notified of a defective product (cracked vial), that was supplied to a customer site on 27 July 2026. The defect was identified upon receipt and was returned to the manufacturing facility. A new vial was supplied. Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). Instructions for Customers/Users Product was not used and was returned to Cyclotek as soon as possible. New vial dispensed and sent to customer to cover patient doses. Action Commencement Date 29/07/2026 Responsible Entity Cyclotek NSW Pty Ltd
Official recall notice
Fludeoxyglucose (18F) Injection (FDG)
Agency: Therapeutic Goods Administration
Official publication date: July 27, 2026
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