| TGA Action ID |
RC-2026-RN-00821-1 |
| Type of Product |
Medicine |
| Product Name/Description |
IMMUNITY FORCE - Wagner Professional Immunity Force 60 Hard Capsules
Product Code: 2695954
All batches within expiry
ARTG: 345563 (cancelled) |
| ARTG Number |
|
| 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 your stock immediately and quarantine all stock of IMMUNITY FORCE on hand to prevent further use or distribution.
•Follow the instructions in the customer letter to raise a claim on the CW Supplier Credits Portal.
•Destroy all affected stock on hand in a documented manner through normal medicines waste or destruction contractor. Record the date, method and quantity destroyed and attach a certificate of destruction or equivalent record.
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 to arrange a refund.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
16/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 367 283 - Sigma Healthcare Customer Service |