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BA ZHENG SAN WAN (Shen Neng Herbal Medicines Group Pty Ltd)

Product Name
BA ZHENG SAN WAN
ARTG
218321
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?
No, continued use is not recommended as its safety is not considered acceptable for a listed medicine
What action should consumers take?
Stop taking this medicine immediately as the safety of batch EYD09317E1 has not been demonstrated by the sponsor. Additionally, batch EYD09317E1 of the medicine expired on 13 September 2022 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 a herbal ingredient (Clematis armandii) which could be confused for Aristolochia species of herbs. Aristolochia herbs contain aristolochic acids, which are not permitted to be present in listed medicines. The sponsor was required to provide testing results to the TGA prior to supply, to demonstrate that their medicine did not contain aristolochic acids, but failed to do so. However, while the safety of the medicine remains unverified, it is unlikely that any stock remains with consumers as the sponsor ceased supply of the medicine in July 2020, withdrew the medicine from supply on 30 June 2021, and the last batch (EYD09317E1) of the medicine expired on 13 September 2022.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
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.
Additional information
This review was conducted as part of a targeted project

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