| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2014-RN-00463-2 |
| Product Name/Description |
Xyntha (moroctocog alfa) 500IU Dual-Chamber Syringe
Batch Number: H19478
ARTG Number: 174838 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
A single syringe of Xyntha 500 IU Dual Chamber Syringe was found to be incorrectly labelled with a Europrean ReFacto AF 3000 IU label. The outer packaging was correctly labelled as Xyntha 500 IU. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pfizer is requesting their customers to quarantine all units from the affected batch number. Pfizer will arrange for the recovery of the affected stock for replacement with unaffected stock. For more details, please see http://www.tga.gov.au/safety/alerts-device-xyntha-syringe.htm . |
| Contact Information |
1800 122 218 - Pfizer Australia Customer Service |