Liang Xue Xiao Feng San a.k.a. Clear the Skin Formula (Sun Herbal Pty Ltd)
Product Name
Liang Xue Xiao Feng San a.k.a. Clear the Skin Formula
Sponsor
ARTG
342378
Date of review outcome
Date of publication
Dec-2024
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?
Do not use if pregnant or likely to become pregnant. Seek advice from a doctor if you have been taking this medicine under these circumstances. For further instructions, please go to the safety alerts page [https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00172-1] on the TGA website.
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 statement for the herbal ingredient Artemisia frigida, as set out under 'What action should consumers take?'. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
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 this medicine from the market, cancelled and withdrew it from further supply.
The TGA issued an infringement notice [https://www.tga.gov.au/news/media-releases/sun-herbal-pty-ltd-fined-18780-alleged-unlawful-supply-complementary-medicine] to the sponsor for supplying this medicine without the mandatory warning statement. The TGA then issued an educational letter to the sponsor outlining the issue with this medicine.
The TGA issued an infringement notice [https://www.tga.gov.au/news/media-releases/sun-herbal-pty-ltd-fined-18780-alleged-unlawful-supply-complementary-medicine] to the sponsor for supplying this medicine without the mandatory warning statement. The TGA then issued an educational letter to the sponsor outlining the issue with this medicine.
Additional information
This medicine was targeted to check its compliance with pregnancy warning statement requirements for Artemisia species