Fludeoxyglucose (18F) Injection (FDG)
OFFICIAL-SOURCE RECALL · AUSTRALIA
Fludeoxyglucose (18F) Injection (FDG) Recall: Classification Class II Reason for the Action It was
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryAustraliaPublishedAugust 4, 2026Last updatedAugust 4, 2026Official source last checkedAugust 20, 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, 2210-5958
- Batch number
- numbers, 2210-5958
- Date code
- dates, Date
- Expiration date
- dates, Date
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 It was identified there was a discrepancy of the recorded activity and volume supplied on the QC Release Forms than the actual activity and volume supplied in the customer vials. As such, the vials may not have met the activity and dose requirements for each customer site. Inadequate activity / volume does not have a direct risk to patient safety, as each dose is measured for activity prior to patient use. However, it could have an impact on patient treatment if a procedure is delayed or cancelled. Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Action as defined within the PRAC). Instructions for Customers/Users Customers were
Hazard
Classification Class II Reason for the Action It was identified there was a discrepancy of the recorded activity and volume supplied on the QC Release Forms than the actual activity and volume supplied in the customer vials. As such, the vials may not have met the activity and dose requirements for each customer site. Inadequate activity / volume does not have a direct risk to patient safety, as each dose is measured for activity prior to patient use. However, it could have an impact on patient treatment if a procedure is delayed or cancelled. Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Action as defined within the PRAC). Instructions for Customers/Users Customers were
Official recall notice
Fludeoxyglucose (18F) Injection (FDG)
Agency: Therapeutic Goods Administration
Official publication date: August 4, 2026
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