3580 (Kaiser Pharmaceutical) Dang Gui Yin Zi (Tangkuei & Tribulus Combination) (Great Grand Care Pty Ltd)
Product Name
3580 (Kaiser Pharmaceutical) Dang Gui Yin Zi (Tangkuei & Tribulus Combination)
Sponsor
ARTG
219954
Date of review outcome
Date of publication
Mar-20
Outcome
Medicine continues to be permitted for supply. Batches released from 30 October 2019 must carry a correct Fallopia Multiflora warning statement on the medicine label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Take note of the warning statement ‘Warning: Fallopia Multiflora may harm the liver in some people. Use under the supervision of a healthcare professional’.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label had an incorrect version of the warning statement ‘Warning: Fallopia Multiflora may harm the liver in some people. Use under the supervision of a healthcare professional’, in that the word ‘Warning:’ was missing. As such, consumers may not be alerted to these safety risks prior to taking the medicine, which may lead to adverse outcomes.
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. The sponsor updated the label to include the correct version of the warning statement.