Zn BioActive (FIT-BioCeuticals Limited)
Product Name
Zn BioActive
Sponsor
ARTG
286547
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply. Batches released from 5 February 2020 must carry a corrected label.
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?
Consider whether the medicine continues to be right for you. If you are pregnant or considering becoming pregnant, do not take Vitamin A supplements without consulting your doctor or pharmacist. When taken in excess of 3000 micrograms retinol equivalents Vitamin A can cause birth defects.
Review scope
Random
Information reviewed
ARTG Record, Labels
Issues related to safety
The mandatory warning statements relating to intake of vitamin A and the risk of birth defects in pregnancy were not positioned correctly on the label of the medicine. As such, consumers may not be alerted to these safety risks prior to taking the medicine which may adversely affect consumer health. However, due to the presence of the warning statements on the label, this is unlikely to pose an immediate safety risk to consumers.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label of the medicine to include the mandatory warning statements before the directions for use of the medicine.