Floradix Floravital Liquid Iron Plus (Endeavour CH Pty Ltd)
Product Name
Floradix Floravital Liquid Iron Plus
Sponsor
ARTG
337398
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
This medicine contains sugars and may have an effect on blood sugar levels. Consider whether the medicine is right for you if you have sensitivities to sugars.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The labels for the medicine (10 mL and 250 mL pack sizes) did not declare the presence of ‘sugars’. Ingredient and substance declarations for listed medicines, including the way they are described on a label, are in place to ensure safe use by consumers who may be affected by their presence. However, this is unlikely to pose an immediate risk to consumer health and safety as the supply of the 10 mL and 250 mL pack sizes ceased in August 2021 and June 2021 respectively, and the affected labels list fruit juice concentrates as excipients, indicating the presence of sugars in the medicine.
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 withdrew the affected medicines from further supply.