Diabecure (Pharmametics Products A Division of Max Biocare Pty Ltd)
Product Name
Diabecure
ARTG
296327
Date of review outcome
Date of publication
Jun-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Do not use this medicine because it is past its expiry date. Seek advice from a suitably qualified health professional if you have been taking this medicine to treat or manage diabetes.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and website of the medicine contained implied claims about diabetes, which is a serious condition that requires diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The references to diabetes have the potential to lead consumers with this condition to delay access to timely medical advice or treatment, resulting in adverse outcomes.
The last batch of the medicine expired in February 2021 and there is no stock in the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
The last batch of the medicine expired in February 2021 and there is no stock in the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and website contained implied claims about diabetes. However, these claims were 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 the medicine. The sponsor cancelled the medicine and withdrew it from further supply.