| TGA Action ID |
RC-2023-RN-00633-1 |
| Type of Product |
Medicine |
| Product Name/Description |
SABRIL 500mg tablet blister pack 100 tablet pack
Batch numbers: 2007A
Expiry date: 11/2025
ARTG : 150021
SABRIL 500mg powder oral sachet 60 sachet pack
Batch number: 2028C
Expiry date: 03/2025
ARTG : 52985 |
| ARTG Number |
52985, 150021 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class I |
| Reason for the Action |
Sanofi-Aventis Australia is recalling specific batches of SABRIL 500mg tablet blister pack (vigabatrin) 100 tablet pack and SABRIL 500mg powder oral sachet (vigabatrin) 60 Sachet pack following detection of a different ingredient contaminating the Product. |
| Instructions for Customers/Users |
Pharmacists will be asked to return stock to their wholesalers. Wholesalers will be asked to cease supply and return stock on hand as well as stock from their pharmacies to the sponsor.
This action may create a shortage in the market. Pharmacists may contact Sanofi to arrange for supply of limited reserve stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Action Commencement Date |
14/07/2023 |
| Responsible Entity |
|
| Contact Information |
Sanofi Customer Service - 1800 152 416
Sanofi Medical Information - 1800 818 806 |