| TGA Action ID |
RC-2026-RN-00765-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fusion Health VIRAFORCE 30 and 60 Capsules
30 Capsule product code: F41052
Batch Number: 4100301, 5013001, 4572A
Expiry Date: 10/2026, 02/2028, 10/2028
60 Capsules product code: F41053
Batch Numbers: 4100302, 5013002, 4572B, 4864
Expiry Dates: 10/2026, 02/2028, 10/2028, 02/2029
|
| ARTG Number |
391340 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
Since 2019, listed medicines containing Andrographis paniculata (Andrographis) for supply in Australia have been required to carry a label warning about the risk of allergic reactions including severe reactions such as anaphylaxis.
However, despite these warnings, the TGA has continued to receive a sustained high number of reports of anaphylaxis associated with Andrographis-containing listed medicines, which are considered low-risk medicines.
Andrographis has now been removed from the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026. This means the ingredient is no longer available for use in new listed (low risk) medicines for supply in Australia. |
| Instructions for Customers/Users |
Wholesalers / Distributors / Pharmacies / Retailers:
• Inspect stock immediately and quarantine all stock of Fusion Health Viraforce (AUST L 391340) on hand to prevent further use or distribution.
• Return affected stock on hand via the returned process outlined in the customer letter.
• Following receipt of a completed response form, customers will be contacted to arrange a credit for the returned stock.
• Retailers(including pharmacies) are to display the attached Public Recall Notice prominently in their storefront to alert consumers to the recall.
Consumers:
• Consumers are advised that if they have the above product, to not use it.
• Consumers who purchased the product from a retail store (pharmacies, health stores) can return the product to their place of purchase.
• Consumers who purchased the product directly from the Fusion website (www.fusionhealth.com.au) will be contacted directly by McPherson's Customer Service on how to proceed.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 550 103 - McPherson's Customer Service |