| TGA Action ID |
RC-2024-RN-00960-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Hepatitis B Immunoglobulin-VF 100IU AU
Batch Number: 3640800146
Expiry Date: 12-Oct-2026
ARTG 61213 |
| ARTG Number |
61213 |
| Action Type |
Product Defect Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Batch contains incorrect fill volume printed on the packaging materials.
A printing error has been identified on the product carton and vial label of Hepatitis B Immunoglobulin-VF 100IU, batch 3640800146, expiry date 12-Oct-2026.
The carton and vial state that the volume of product contained in the vial is 0.43mL, however, the carton and vial label should state 1.00mL as this is volume within the vial. |
| Instructions for Customers/Users |
Product Defect Alert
· CSL Behring can confirm that this batch can continue to be prescribed and administered in accordance with the Hepatitis B Immunoglobulin – VF PI which can be found at https://labeling.cslbehring.com/PI/AU/Hepatitis-B-Immunoglobulin-P/EN/Hepatitis-B-Immunoglobulin-VF-Product-Information.pdf. If you receive this batch, please ensure you administer the full contents of the vial (1mL) to receive the required dose.
· If two vials (2mL) of the impacted 100IU vial was dosed as a result of the labelling error, review the patient as required.
Warehouse Product Defect Correction
· For warehouses only, the stock currently in the 3PL distribution centres, including National Reserve will be returned to CSL Behring for correction.
This action has been finalised on 12/2/2025. |
| Action Commencement Date |
31/10/2024 |
| Responsible Entity |
|
| Contact Information |
1800 642 865 - Medical Information team |