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Cellife Anti-Oxidant (Cellife Health Products Pty Ltd)
Product Name
Cellife Anti-Oxidant
Sponsor
Date of review outcome
Date of publication
Mar-2024
Outcome
Medicine continues to be permitted for supply. Batches released after December 2022 must carry a corrected label.
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?
Use in children under 12 years is not recommended. Do not use if pregnant or likely to become pregnant. Do not use while breastfeeding. Seek advice from a suitably qualified health practitioner if you have been taking this medicine under these circumstances.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label for this medicine was missing the mandatory warning statements for the herbal ingredient Foeniculum vulgare, as set out under 'What action should consumers take?' above. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
However, given the affected batches of this medicine expired in October 2022 and there is no affected stock on the market, it is unlikely to pose an immediate risk to consumer health and safety.
However, given the affected batches of this medicine expired in October 2022 and there is no affected stock on the market, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor updated the label to include the mandatory warning statements set out under 'What action should consumers take?'. Nevertheless, the TGA 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 fennel ingredients