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Chuan Xiong Cha Tiao Wan (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
Chuan Xiong Cha Tiao Wan
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
The affected batch of the medicine (EYD03815C1) expired in November 2020 and consumers should not be taking expired medicines
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The medicine contains the herbal ingredient Cinnamomum cassia which may contain coumarin, a potentially harmful substance. There are quantity restrictions in place for coumarin to ensure the safe use of listed medicines. The sponsor did not have documentation to support their certification that batch EYD03815C1 of the medicine complied with safety limits for coumarin. However, given the affected batch of the medicine expired in November 2020 and there is no affected stock on the market, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/media-release/shen-neng-herbal-medicines-group-pty-ltd-fined-53280-alleged-breaches-therapeutic-goods-legislation) to the sponsor for failing to provide information requested as part of the compliance review.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor provided additional information and updated the ARTG listing for the medicine.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor provided additional information and updated the ARTG listing for the medicine.
Additional information
This review was conducted as part of a targeted project