| TGA Action ID |
RC-2026-RN-00792-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Faulding Immune Combat 100s
Product Code: M004022
All batches within expiry |
| ARTG Number |
385872 |
| 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 |
Distributors/retailers
• Inspect stock immediately and quarantine all stock of Faulding Immune Combat on hand to prevent further use or distribution.
• Retailers Wholesale/distributors: dispose of the product and provide a destruction certificate to consumercontact@symbion.com.au
• For Pharmacy retailer: return the product to your wholesaler
• Following receipt of a completed response form, confirmation of disposal for wholesalers/returned stock from pharmacy retailers, Symbion will contact customers to arrange a credit for the returned/disposed stock.
Consumers
• Consumers are advised that if they have the above product, to not use it.
• Consumers can return the product to the place of purchase or contact Symbion Pty Ltd at consumercontact@symbion.com.au or call 1300 430 611 to arrange the return of product for a refund.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
8/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 430 611 - Symbion Customer Service |