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SPORT (Mannatech Australia Pty Ltd)

Product Name
SPORT
ARTG
330992
Date of review outcome
Date of publication
Mar-22
Outcome
Medicine continues to be permitted for supply. Batches released from 30 July 2021 must carry a corrected label containing the amended maximum daily dose of 3 capsules per day.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Only take a maximum of 3 capsules per day. Seek advice from a healthcare practitioner if you have been taking 4 capsules per day.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The medicine contained an amount of chromium that exceeded the permitted limit for listed medicines at the labelled maximum daily dose (4 capsules). Ingredient limits for listed medicines are in place to ensure their safety. Whilst exceeding this limit is unacceptable, current data indicates that the amount in the medicine is unlikely to pose an immediate safety concern. In addition, supply of the medicine was temporarily ceased in June 2021 for the purpose of repackaging with the correct label. Thus, the medicine is unlikely to pose a significant risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The sponsor temporarily ceased the supply of the medicine and amended the maximum daily dose on the label. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.

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