URGENT CONSUMER MEDICINE RECALL; and
RETAIL PRODUCT DEFECT CORRECTION
Batches: Q00370 & 32926
Date: 19-02-2021 12.00pm AEST
TGA Reference: RC-2021-RN-00367-1
Following consultation with the Therapeutic Goods Administration (TGA), ATP Science is undertaking a Consumer Level Recall of the above product/s. We are contacting you as our records indicate the potentially affected product has been supplied to you.
|ISSUE||• The Therapeutic Goods Administration (TGA) has recently undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant, or likely to become pregnant.|
• In light of this, as of the 1st February 2021 the TGA is advising that medicines which contain Artemisia ingredients should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant.
|HAZARD||• Extracts from Artemisia species have been shown to harm the developing embryo in animals. These types of studies are used to identify risks for medicines used during pregnancy in humans. Studies of artemisinin, a chemical found in Artemisia species, and related compounds have also shown the potential for both pregnancy loss (miscarriage) and developmental abnormalities in animals.|
|INSTRUCTIONS FOR USERS||Consumers are being advised to return their product to the place of purchase for a refund.|
Consumers who purchased direct from ATP Science are requested to contact ATP Science (contact details below) to organise a refund.
|CORRECTIVE ACTION||Following this action, we have gone ahead and re-labelled all of our current stock to include the below warning.|
‘Do not use if pregnant or likely to become pregnant’
|CONTACT INFORMATION||For questions regarding this letter, please contact: ATP Science Customer Support Team|
Email: firstname.lastname@example.org Phone: 1300 767 110
We apologise for any inconvenience caused to you and please do not hesitate to contact our friendly customer support team below with your concerns, questions, or return requests for the relevant Immune RX batches and we will be happy to help.
To access the research paper on Artemisia please click through below, if you have concerns over the paper we would recommend taking a copy to your health practitioner to discuss in more detail.
A website link: https://pubmed.ncbi.nlm.nih.gov/32622917/
Details of paper:
González R, Pons-Duran C, Bardají A, Leke RGF, Clark R, Menendez C. Systematic review of artemisinin embryotoxicity in animals: Implications for malaria control in human pregnancy. Toxicol Appl Pharmacol. 2020 Sep 1;402:115127. doi: 10.1016/j.taap.2020.115127. Epub 2020 Jul 2. PMID: 32622917.