Thompson's Immunofort (Integria Healthcare Australia Pty Ltd)
Product Name
Thompson's Immunofort
ARTG
320459
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains Andrographis, which may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for a batch ([B]111059]) of the medicine was missing the mandatory warning statement for Andrographis, as set out under 'What actions should consumers take'. 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 affected batch was only supplied in New Zealand, and therefore, a recall was not required in Australia. The relevant New Zealand authorities have been notified of this matter.
However, the affected batch was only supplied in New Zealand, and therefore, a recall was not required in Australia. The relevant New Zealand authorities have been notified of this matter.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to Andrographis paniculata