| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00163-1 |
| Product Name/Description |
Restylane SubQ Lidocaine (Used for facial tissue augmentation)
Lot numbers: 11907 and 11516
Article numbers: 10-77001, 107702, 10-77005
ARTG number: 193814 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a technical issue with the blister pack of the Restylane SubQ Lidocaine syringes during an internal quality control procedure. The defect affects the blister pack and therefore the external sterility of each syringe can no longer be guaranteed. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are being requested to return all affected batches in the reply paid envelope provided with recall letter. Unaffected replacements will be provided upon receipt of the returned stock. |
| Contact Information |
1800 144 944 - Galderma Australia |