OFFICIAL-SOURCE RECALL · AUSTRALIA
Irinotecan HCL 206mg In 0.9% Sodium Chloride in Polyolefin Bag Recall: Classification Class II Reason for
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Irinotecan HCL 206mg In 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
- Manufacturer
- See official notice
- Lot number
- numbers, BK260726123
- Batch number
- numbers, BK260726123
- 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 Upon receipt of compounding product, Irinotecan HCL, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use. The product was discarded and not administered. This market action does not affect any other compounded batches of Irinotecan HCL or any other Slade Health products. 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 The product has been discarded by the customer. A replacement product was not provided as alternate stock was already available at the hospital. Action Commencement Date 10/08/2026 Responsible Entity Slade Health Pty Ltd
Hazard
Classification Class II Reason for the Action Upon receipt of compounding product, Irinotecan HCL, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use. The product was discarded and not administered. This market action does not affect any other compounded batches of Irinotecan HCL or any other Slade Health products. 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 The product has been discarded by the customer. A replacement product was not provided as alternate stock was already available at the hospital. Action Commencement Date 10/08/2026 Responsible Entity Slade Health Pty Ltd
Official recall notice
Irinotecan HCL 206mg In 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Agency: Therapeutic Goods Administration
Official publication date: September 27, 2026
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