K2C2D3 (BlueSkyGreenEarth Herbs Pty Ltd)
Product Name
K2C2D3
Sponsor
ARTG
287105
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, only with involvement from a health practitioner. Follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health practitioner if you have been taking this medicine at a dose of one or more tablets per day. One tablet of this medicine exceeds the permitted limits for vitamin D (colecalciferol) in listed medicines for both adults and children, and vitamin K (menaquinone 7) in children under the age of 18.
Review scope
Random
Information reviewed
ARTG Record, Labels
Issues related to safety
One tablet of the medicine contains 41.68 micrograms of vitamin D and 167 micrograms of vitamin K, which exceed the permitted limits for these ingredients in listed medicines. The maximum permitted limit for vitamin D is no more than 25 micrograms. The maximum permitted dose of vitamin K for children under 10 years and children between 10-18 years are 45 micrograms and 90 micrograms, respectively. Ingredient limits are in place to ensure the safety of listed medicines. The label of the medicine does not include any relevant dosage instructions or warning statements in relation to the maximum allowable doses of vitamin D and vitamin K in adults and children. Inadequate labelling in relation to appropriate dosing and warnings is unacceptable where there are ingredient limits, however current data indicates that the amounts of vitamin D and vitamin K in 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
TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.