Rapid-Guard Immune Boost (Ausway Pharmaceutical Pty Ltd)
Product Name
Rapid-Guard Immune Boost
Sponsor
ARTG
331436
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply. One batch ([B] 2004) of this medicine has been recalled by the sponsor due to the label not including a required warning statement. All future batches of the medicine must carry a corrected label.
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 allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for 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.
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 recalled the affected batch of the medicine from the market. The sponsor also 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