Xenadrine (Iovate Health Sciences Australia Pty Ltd)
Product Name
Xenadrine
ARTG
325627
Date of review outcome
Date of publication
Dec-22
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 1 capsule within a 3-hour period. Seek advice from a healthcare practitioner if you have been taking 2 capsules within a 3-hour period.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The label implied that taking the medicine during pregnancy and/or breastfeeding is considered acceptable in some circumstances. However, the medicine is not recommended to be taken by pregnant women or women who are breastfeeding.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the 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