Fu Gui Ba Wei Tang ak.a. Rehmannia Eight Vitality Formula (Sun Herbal Pty Ltd)
Product Name
Fu Gui Ba Wei Tang ak.a. Rehmannia Eight Vitality Formula
Sponsor
ARTG
148050
Date of review outcome
Date of publication
Jun-23
Outcome
Medicine is no longer permitted to be supplied and has been recalled by the sponsor
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Use in children under 12 years is not recommended. Do not use if pregnant or likely to become pregnant. Do not use while breastfeeding. Seek advice from a suitably qualified health practitioner if you have been taking this medicine under these circumstances. For further instructions, please go to the safety alerts page on the TGA website. https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01557-1
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing the mandatory warning statements for the herbal ingredient Foeniculum vulgare, as set out under 'What action should consumers take?'. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
All batches of this medicine were recalled and are therefore unlikely to pose a safety risk to consumers.
All batches of this medicine were recalled and are therefore unlikely to pose a safety risk to consumers.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor recalled all batches of this medicine from the market, cancelled and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to fennel ingredients