| TGA Action ID |
RC-2026-RN-00871-1 |
| Type of Product |
Medicine |
| Product Name/Description |
CAELYX doxorubicin hydrochloride 50 mg/25 mL concentrated injection vial
Product Code: 2321B0327
Lot Number: 5I021D
Expiry Date: 30/04/2027 |
| ARTG Number |
79921 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Baxter has received customer reports of improperly crimped aluminium vial seals in which removal of the flip-off cap resulted in the entire vial closure assembly, including the aluminium seal and rubber stopper, detaching from the vial and leaving the vial open. The affected lot number was distributed beginning 03-Feb-2026.
Inadequate crimping of the aluminium vial seal may compromise container closure integrity and result in unintended occupational exposure or a delay in therapy. In the unlikely event that compromised product is administered, serious infection, including sepsis, organ failure, or death, could occur. The overall risk is considered low because the defect is readily visible and is expected to be identified during routine inspection and preparation. To date, Baxter has not received any reports of adverse events related to this problem. |
| Instructions for Customers/Users |
During pharmacy preparation, visually inspect the vials before use and following removal of the flip-off cap. If a vial exhibits any closure abnormalities, leakage, or signs of compromised integrity, please remove it from use before administration and contact Baxter Product Surveillance |
| Action Commencement Date |
28/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 229 837 - Baxter Healthcare Customer Service |