Bioglan Healthy Kids Rest + Calm Chewable (Natural Bio Pty Ltd)
Product Name
Bioglan Healthy Kids Rest + Calm Chewable
Sponsor
ARTG
304747
Date of review outcome
Date of publication
Sep-21
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?
This medicine contains sugars and sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to these substances.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The medicine contains 'sugars' and 'sulfites', neither of which were declared on the label. Sugars and sulfites are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances.The label also made a false declaration 'Contains no added sugars'. This false declaration poses safety risks to some consumers with sugar sensitivity.
Whilst the undeclared presence of sugars and trace residue of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to sugar sensitivity and trace amounts of sulfites (such as anaphylaxis) are rare. In addition, supply of the medicine ceased in January 2020 and very limited stocks remained on the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Whilst the undeclared presence of sugars and trace residue of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to sugar sensitivity and trace amounts of sulfites (such as anaphylaxis) are rare. In addition, supply of the medicine ceased in January 2020 and very limited stocks remained on the market. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.