Ultra Caps (WLANZ)
Product Name
Ultra Caps
Sponsor
ARTG
338271
Date of review outcome
Date of publication
Sep-2023
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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been using this medicine as a nutritional supplement following weight loss surgery.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The website for this medicine stated that it could be used as a nutritional supplement following weight loss surgery, which is not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitability qualified health professional when required, which may result in adverse outcomes. While advertising of this nature is unacceptable, references to this medicine have been removed from the website, supply of this medicine ceased in June 2022 and the website advised consumers to see a healthcare professional if symptoms persisted. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims that it may support nutritional deficiencies following weight loss surgery. However, this claim was 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 and withdrew it from further supply.