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OFFICIAL-SOURCE RECALL · AUSTRALIA

Irinotecan HCL 206mg In 0.9% Sodium Chloride in Polyolefin Bag Recall: Classification Class II Reason for

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CountryAustraliaPublishedSeptember 27, 2026Last updatedSeptember 27, 2026Official source last checkedAugust 20, 2026 at 7:44 PM UTC

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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

Read the official AU_TGA_DRAC recall notice →

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