| TGA Action ID |
RC-2026-RN-00791-1 |
| Type of Product |
Medicine |
| Product Name/Description |
AYUNA AMA CARE 60 /100 VEG capsules
Batch: 2038
Expiry Date: 06/2028
ARTG 282724 (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 stock immediately and quarantine affected stock on hand to prevent further use or distribution.
• Return affected stock on hand per the instructions in the Customer Letter.
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.
• If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
9/10/2026 |
| Responsible Entity |
|
| Contact Information |
0402 282 745 - Satheesh Kumar |