IMMUNITY FORCE (RF Six Pty Ltd)
Product Name
IMMUNITY FORCE
Sponsor
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification
What action should consumers take?
None
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for a batch of the medicine was missing the mandatory warning statement 'Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice'. This warning statement is necessary to ensure the safe use of the medicine and to alert consumers to safety risks prior to taking the medicine.
However, the medicine was not recalled following the sponsor's assurance that the affected batch had not been supplied to the market and all future batches of the medicine will carry a corrected label.
However, the medicine was not recalled following the sponsor's assurance that the affected batch had not been supplied to the market and all future batches of the medicine will carry a corrected label.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label to include the required warning statement.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to Andrographis paniculata