| TGA Action ID |
RC-2024-RN-00462-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Vabysmo Vial 28.8mg/0.24ml Vial Starter Pack
Material Number: 11015775
Packed Batch Number: B1542B02, B1537B14
Expiry date: June 2026
ARTG 369935 |
| ARTG Number |
369935 |
| Action Type |
Recall |
| Action Level |
Wholesale |
| Hazard Classification |
Class I |
| Reason for the Action |
The blister packaging of a low percentage of individual co-packaged blunt Transfer Filter Needles (TFN) may have been damaged. The damage to the blister consists of a tear, located close to the needle hub of the TFN, at the bottom of the packaging which is covered by a layer of paper.
Based on the defect pattern, the tear is likely to be caused by pressure applied to the blister around the location of the needle hub. When the blister is torn, the sterility of the TFN may be compromised, which poses a potential safety risk for patients. To date, this defect has only been found at the packaging site. Roche has not received any reports from the market for the observed defect pattern.
The recall does not affect any other batch of Vabysmo vial 28.8mg/0.24ml Starter Pack in Australia. |
| Instructions for Customers/Users |
Customers are to inspect, and quarantine affected stock immediately to prevent further distribution and use.
Once the acknowledgement form is received Roche will organise for collection of affected stock.
This action has been closed out on 12/09/2024 |
| Action Commencement Date |
13/06/2024 |
| Responsible Entity |
|
| Contact Information |
aabha.shah@roche.com - Roche Products Pty Ltd |