| TGA Action ID |
RC-2026-RN-00870-1 |
| Type of Product |
Medicine |
| Product Name/Description |
AV/AT, LivoClear, Ly)mex
All batches within expiry
ARTG's: 124124, 281590, 291201 (cancelled) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
AV/AT (AUST L 124124), LivoClear (AUST L 281590), Ly)mex (AUST L 291201) |
| 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.
The ARTG listings for all three products were cancelled on 23 September 2026. BlueSkyGreenEarth Herbs Pty Ltd ceased sale and dispatch on 21 September 2026. |
| Instructions for Customers/Users |
Distributors/retailers:
- Inspect stock immediately and quarantine all affected stock on hand to prevent further use or distribution.
- Follow the instructions in the Customer Letter regarding the return or disposal of affected stock.
- BlueSkyGreenEarth Herbs Pty Ltd will contact customers to arrange a refund or credit for affected stock.
Consumers:
- Consumers are advised that if they have the above products, to not use them.
- Consumers can return the product to the place of purchase or contact BlueSkyGreenEarth Herbs on 1300 133 807 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 |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
1300 133 807 - BlueSkyGreenEarth Herbs |