Jingzhi Kesou Tanchuan Wan tablets

Notice type: Warning

Date: 31/03/2010

 

Product name or type:
Jingzhi Kesou Tanchuan Wan tablets


Reference:
QDR-H-10-168


Authorisation Number:
None - This is not an authorised medicine


Active Substance:
Various natural herbal substances


Manufacturer Or Supplier:
Manufacturer unknown. The product is known to be distributed in Ireland by Ekong International (UK) Ltd but there is the potential that it is supplied from other sources.


Serial Or Batch Number And Expiry Date:
All batches.


Recall Classification:
Patient level


Target Audience:
The General Public 
Users of Traditional Chinese Medicines
Suppliers and Retailers of Traditional Chinese Medicines
Practitioners of Traditional Chinese Medicines


Problem Or Issue:
The IMB has become aware of the presence of an illegal herbal medicine on the Irish market. It was found that English language labelling had been applied to packs to conceal the Chinese text, detailing the presence of aristolochic acid. 

Aristolochic acids occur naturally in the herb Aristolochia manchuriensis and are known to be toxic to the kidney. Aristolochic acids are regulated in Ireland as prescription-only medicines.

It is known that this product has been distributed to some practitioners and retailers of Traditional Chinese Medicines in Ireland by Ekong International (UK) Ltd and it is possible that the product is being supplied from other sources. 


Background Information Or Related Documents:

Please see below link to an image of the product

Jingzhi tablets image 1.docx 

Please see below links to previous warning statements on aristolochic acid-containing herbal products.

Jingzhi Kesou Tanchuan Wan tablets Document



Actions To Be Taken:
Any retailers who have identified Jingzhi Kesou Tanchuan Wan Tablets in their possession should immediately quarantine the stock and notify the IMB at the contact details below. If retailers have supplied this product to customers, the IMB is requesting that every effort be made to contact those customers, so that the product can be quarantined and the IMB can be contacted.

Any persons who are in the possession of Jingzhi Kesou Tanchuan Wan Tablets should place the stock in a safe place and immediately contact the IMB, at the details below.

Any patients or members of the public who are using, or have used, Jingzhi Kesou Tanchuan Wan Tablets are advised to immediately stop taking this product and consult their pharmacist or doctor, even if they have already stopped taking the product. When consulting their doctor or pharmacist, patients may find it useful to take a copy of this notification with them.

The IMB is advising trade and other relevant organisations of the above, so that they may inform their members, who may, in turn, inform any customers who have taken the product. 


Further Information:

Market Compliance
Health Products Regulatory Authority, 
Earlsfort Terrace, 
Dublin 2, 
Ireland   
Tel:   +353-1-6764971 (office) 
Fax:  +353-1-6764061


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