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Microgenics Calcium Complete , RF Six Pty Ltd, CON-328
Product name
Microgenics Calcium Complete
Sponsor name
RF Six Pty Ltd
ARTG
309330
Batches
Q8237G Q8240G
Consent start
Consent no.
CON-328
Standard
Schedule 2 of the Therapeutic Goods Standard for Tablets, Capsules and Pills (TGO101) Order 2019 relating to assay limits for boron content.
Non-compliance with standard
The batchesdo not conform to the Schedule 2 requirements of the TGO101 for boron
content as it does not comply with the upper limit of 125% of the stated content
for an active ingredient.
Conditions imposed
The content of boron must be no less than 90% and no more than 160% overage of
the stated content on the label.Any future s14 exemption applications from the
same sponsor regarding the same product with the same issue will require major
justifications.
Therapeutic product type
Listed complementary medicines