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HUO XIANG ZHENG QI SHUI (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
HUO XIANG ZHENG QI SHUI
ARTG
122349
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Do not take this medicine because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Laboratory Results, Manufacturing Documentation, Sample
Issues related to safety
The medicine contains the herbal ingredients Areca catechu and Citrus reticulata which may contain arecoline and oxedrine, respectively, which are potentially harmful substances. There are quantity restrictions in place for arecoline and oxedrine to ensure the safe use of listed medicines. The sponsor stated and certified that the medicine complied with these requirements. However, they did not have documentation to support this. Subsequent testing indicated that the quantities of arecoline and oxedrine in the medicine were within permissible limits and unlikely to pose a safety risk to consumers.
Issues related to efficacy
The label for the medicine did not include an expiry date. Expiry dates are required to be presented on medicine labels as expired medicines may no longer work as expected.
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply.
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.
The TGA then issued an educational letter to the sponsor outlining the issues with the medicine.
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.
The TGA then issued an educational letter to the sponsor outlining the issues with the medicine.
Additional information
This review was conducted as part of a targeted project