| TGA Action ID |
RC-2026-RN-00809-1 |
| Type of Product |
Medicine |
| Product Name/Description |
MEDIX Cold & Flu Day & Night & COLES Cold & Flu Day & Night
All Batches within Expiry |
| ARTG Number |
353367, 353545 |
| 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/Wholesalers
• Inspect stock immediately and quarantine all stock of product on hand to prevent further use or distribution.
• Return all affected stock on hand with the completed response form to Nova Pharmaceuticals.
• Following receipt of returned stock and a completed response form, Nova Pharmaceuticals will contact customers to arrange refund or credit.
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 |
14/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 002 171 - Nova Pharmaceuticals |