SHEN NENG RUN CHANG WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
SHEN NENG RUN CHANG WAN
ARTG
67283
Date of review outcome
Date of publication
Jun-23
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?
Do not take this medicine because it is past its expiry date. Refer to 'Issues related to safety' below for further information. Seek advice from a health practitioner if you are concerned about your health.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Laboratory Results, Manufacturing Documentation, Sample
Issues related to safety
This medicine was found to contain amygdalin, a substance that is not permitted for use in listed medicines.
In addition, manufacturing documents from the sponsor contained medicine composition information that was inconsistent with the ARTG record. These inconsistencies could affect the quality and therefore the safety of this medicine.
While the safety of this medicine was therefore considered to be unacceptable, current data indicate this medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, the sponsor stopped supply of this medicine in July 2020, and the affected batch expired on 16 December 2021.
In addition, manufacturing documents from the sponsor contained medicine composition information that was inconsistent with the ARTG record. These inconsistencies could affect the quality and therefore the safety of this medicine.
While the safety of this medicine was therefore considered to be unacceptable, current data indicate this medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, the sponsor stopped supply of this medicine in July 2020, and the affected batch expired on 16 December 2021.
Issues related to efficacy
Manufacturing documents from the sponsor contained medicine composition information that was inconsistent with the ARTG record. These inconsistencies could affect the quality and therefore the efficacy of this medicine.
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/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 notified the sponsor that amygdalin was detected in this medicine. The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
The TGA notified the sponsor that amygdalin was detected in this medicine. The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This review was conducted as part of a targeted project