Hydroxycut Hardcore Elite (Nutrition Depot Oceania Pty Ltd)
Product Name
Hydroxycut Hardcore Elite
Sponsor
ARTG
311665
Date of review outcome
Date of publication
Mar-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Take a maximum of 4 capsules per day. Seek advice from a healthcare practitioner if you have been taking 6 capsules per day.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The product contains an amount of caffeine that exceeds the permitted limit for listed medicines if taken at the labelled maximum daily dose (6 capsules). Ingredient limits for listed medicines are in place to ensure their safety. While exceeding this limit is unacceptable, current data indicates that the amount in the medicine is unlikely to pose an immediate 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
TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.