| TGA Action ID |
RC-2026-RN-00836-1 |
| Type of Product |
Medicine |
| Product Name/Description |
BioPractica ImmunePro Plus 60 Tablets
Batch Number: 41309
Expiry Date: 28/02/2027
Batch Number: 43660
Expiry Date: 31/03/2028
Batch Number: 45266
Expiry Date: 30/01/2029 |
| ARTG Number |
393514 |
| 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 and retailers:
- Inspect their stock immediately and quarantine affected stock on hand to prevent further use.
- Return the completed Customer Response Form even if they do not have any affected stock.
- Notify any downstream commercial customers to whom they have supplied the affected stock and instruct them to immediate cease supply and follow the recall instructions.
Consumers:
- Consumers are advised that if they have the above products, do not use them.
- Consumers can contact Nuchev Practitioner on 1300 551 077 or productrecalls@nuchev.com.au to arrange the return and refund of the product.
- If someone is suspected of having anaphylaxis, call for emergency medical help immediately by dialling ‘000’. |
| Action Commencement Date |
20/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 551 077 or productrecalls@nuchev.com.au - Customer Service |