Medicine continues to be permitted for supply. One batch of this medicine (15500101) has been recalled due to the label not including the required warning statements for Foeniculum vulgare.
Batches released after December 2022 must carry a corrected label.
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?
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-01566-1
Targeted (see Additional Information below)
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing two of 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.
The only affected batch (Batch 15500101) was recalled and is 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 batch 15500101 from the market and updated this medicine's label to carry the required warnings. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
This medicine was targeted to check its compliance with warning statement requirements related to fennel ingredients
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.