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Cardiotone (Global Therapeutics Pty Ltd)
Product Name
Cardiotone
Sponsor
ARTG
306910
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor’s certification. However, follow the recommended actions below.
What action should consumers take?
Do not use this medicine because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Manufacturing Documentation
Issues related to safety
None
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
During the review, sponsorship of the medicine changed to McPhersons Consumer Products Pty Ltd, who cancelled the medicine and withdrew it from further supply. The TGA issued an educational letter to the sponsor. The sponsor provided further information about the medicine and no further action was required.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions for the substance safrole