| TGA Action ID |
RC-2026-RN-00805-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Chuan Xin Lian Antiphlogistic Tablet
Batch Number: B4C1 (all unexpired batches)
Expiry Date: 30 MAY 2029 |
| ARTG Number |
432432 |
| 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 Chuan Xin Lian Antiphlogistic Tablet on hand to prevent further use or distribution.
• Return affected stock on hand with the completed response form to Shen Neng Herbal Medicines Group.
• Following receipt of returned stock and a completed response form, the sponsor will contact customers to arrange a refund for the returned stock.
Consumers:
• Consumers are advised that if they have the above product, do not use it.
• Consumers can return the product to the place of purchase, or contact the sponsor 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 |
13/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9416 9831 / enquiries@shennenggroup.com - Shen Neng Herbal Medicines |