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RecoveR8 (Tismor Health & Wellness Pty Ltd)

Product Name
Date of review outcome
Date of publication
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
This medicine contains benzoates and sorbates. Consider whether it is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Be aware that this medicine is not permitted by the TGA to prevent ageing, the development of cancer, autoimmune disorders, cataract, rheumatoid arthritis, cardiovascular and neurodegenerative diseases, or to reduce joint pain, swelling and arthritis. Seek advice from a suitably qualified health practitioner if you have been or are intending on using this medicine for these purposes.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to helping with recovery before and after physical activity, reducing muscular fatigue and damage, improving physical fitness, boosting the immune system, enhancing sleep quality and mental focus, supporting healthy blood flow and circulation, or restoring general health and wellbeing.
Review scope
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
This medicine contains benzoates and sorbates, which were not declared on the website for this medicine. Benzoates and sorbates are required to be declared on the labels and in the advertising of medicines that contain them, as they may cause adverse reactions in individuals with allergies or sensitivities to this group of substances. However, the label for this medicine includes the statement 'The product contains potassium sorbate and sodium benzoate', which alerts consumers to the presence of these substances in this medicine.
The website for this medicine contained claims specified in 'What action should consumers take?' above. These claims were related to serious forms of a disease that require diagnosis, treatment or supervision by a suitably qualified health professional, or were not permitted for listed medicines without prior evaluation by the TGA. References to serious forms of a disease or conditions that have the potential to lead consumers to delay access to timely medical advice or treatment when required, may result in adverse outcomes. While advertising of this nature is unacceptable, these claims have been removed from the website. Furthermore, the label for this medicine advised consumers to seek advice from a healthcare professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine 'RecoveR8' implied that it may help with recovery before and after physical activity. The label and advertising for this medicine also contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine, withdrew it from further supply and removed the advertisement from their website.

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