JIN GUI SHEN QI WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
JIN GUI SHEN QI WAN
ARTG
217716
Date of review outcome
Date cancellation takes effect
Date of publication
Mar-20
Outcome
Medicine is no longer permitted to be supplied and has been recalled by the sponsor
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 and seek advice from a healthcare practitioner. For further instructions, please go to the safety alerts page on the TGA website
Review scope
Targeted
Information reviewed
ARTG Record, Laboratory Results
Issues related to safety
The product contains an amount of alkaloids, a naturally occurring substance in an ingredient that is added to the formulation of this medicine, that exceeds the limit that is permitted for listed medicines. Exceeding this limit may adversely affect consumer health.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. TGA subsequently cancelled the medicine and withdrew permission for further supply
Grounds for cancellation
The goods were not eligible for listing as they did not meet the requirements set out in Schedule 4 of the Therapeutic Goods Regulations.