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Mediherb Bacopa Complex (N/F) (Integria Healthcare Australia Pty Ltd)
Product Name
Mediherb Bacopa Complex (N/F)
ARTG
104361
Date of review outcome
Date of publication
Jun-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
None
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Manufacturing Documentation
Issues related to safety
The medicine contains the herbal ingredient rosemary oil which may contain safrole, a potentially harmful substance. There are quantity restrictions in place for safrole to ensure the safe use of listed medicines. The sponsor did not have documentation to support their certification that the medicine complied with safety limits for safrole. However, subsequent testing indicated that the quantity of safrole in the medicine is within permissible limits and unlikely to pose a 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
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.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions for the substance safrole