Immune + (JSHealth Vitamins Pty Ltd)
Product Name
Immune +
Sponsor
ARTG
Date of review outcome
Date of publication
Jun-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this 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, Manufacturing Documentation
Issues related to safety
The label for batch B22374R of this medicine was missing the mandatory warning statement for the ingredient Andrographis paniculata, as set out under 'What action should consumers take'. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine.
However, this medicine was not recalled following the sponsor's assurance that there was no stock of the affected batch in the market. Subsequent batches of this medicine carry a corrected label.
However, this medicine was not recalled following the sponsor's assurance that there was no stock of the affected batch in the market. Subsequent batches of this medicine carry a corrected label.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/jshealth-vitamins-fined-13320-alleged-unlawful-supply-complementary-medicine) to the sponsor for supplying batches of this medicine without the mandatory warning statements. The TGA then issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to Andrographis paniculata