| TGA Action ID |
RC-2025-RN-00427-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Topiramate Powder 25g & 100g
Lot Number: 197735
Expiry Date: 31/01/2026
ARTG not on the register |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
Following a customer complaint regarding the darkening of Topiramate, MEDISCA conducted analytical testing of stock on hand. Testing results revealed an Out of Specification (OOS) for the following:
Assay – 97.0% (Specifications 98.0% - 102.0%)
Fructose 0.9% (Specifications 0.3%). This OOS has resulted in an OOS for Total impurities within the product.
According to some scientific literature, Medisca believe that the threefold increase in fructose levels in the product is unlikely to cause any harm to patients. However, there is a quality problem with the product.
This recall does not apply to any other lots of Topiramate or any other Medisca products.
The affected Lot 197335 has been distributed to customers since May 2024. |
| Instructions for Customers/Users |
Customers are to:
- Destroy affected stock and provide evidence of destruction to Medisca.
-Alternatively, return affected stock to the sponsor for distruction.
This action has been closed out on 23/06/2025 |
| Action Commencement Date |
2/05/2025 |
| Responsible Entity |
|
| Contact Information |
1300 786 392 - Medisca Australia Customer Service |