| TGA Action ID |
RC-2026-RN-00891-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cold & Flu Strike 14T, 30T and 60T
All batches within expiry
ARTG 299587 (cancelled) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
430085 Cold & Flu Strike 14T, 430086 Cold & Flu Strike 30T, 430087 Cold & Flu Strike 60T |
| 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 the products on hand to prevent further use or distribution.
• Return affected stock on hand with the completed response form, or dispose of stock locally with supporting evidence.
• Following receipt of returned stock and a completed response form, Herbs of Gold will contact customers to arrange an alternative replacement product, a refund or a credit.
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 |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
02 9545 2633 / 1800 852 222 - Herbs of Gold Customer Service |