Hydroxycut Pro Clinical (Iovate Health Sciences Australia Pty Ltd)
Product Name
Hydroxycut Pro Clinical
ARTG
321610
Date of review outcome
Date of publication
Mar-2024
Outcome
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 187 mg caffeine per dose (2 tablets). A cup of instant coffee contains approximately 80 mg of caffeine. Seek advice from a healthcare practitioner if you have been taking 2 capsules within a 3-hour period. The last batch of this medicine expired in April 2023. Do not take this medicine as it is past its expiry date.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
This medicine contains an amount of caffeine that exceeds the permitted limit for listed medicines if taken at the labelled single dose of 2 tablets. Ingredient limits for listed medicines are in place to ensure their safety. While exceeding this limit is unacceptable, current data indicates that the amount of caffeine in a single dose of this medicine 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 TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine