Potentially Harmful Traditional Chinese Medicinal Products

Notice type: Warning

Date: 07/11/2007

 

Product name or type:
Xie Gan Wan Tablets, Bai Tou Weng Wan Tablets, Chuan Xiong Cha Tiao Wan Tablets and Xiao Qin Long Wan Tablets


Reference:
HPRA Ref: QDR-H-07-411


Authorisation Number:
None


Active Substance:
Aristolochic Acids


Product Classification:
Chinese Medicinal Products


Manufacturer Or Supplier:
Manufacturer/Supplier of Xie Gan Wan Tablets - Ekong International (UK) Ltd. 

Manufacturer of Bai Tou Weng Wan Tablets - Lanzhou Taibao Pharmaceutical Factory, China. 

Manufacturer of Chuan Xiong Cha Tiao Wan Tablets - Lanzhou Taibao Pharmaceutical Factory (Lanzhou Minshan Pharmaceutical Factory), China. 

Manufacturer of Xiao Qin Long Wan Tablets - Lanzhou Taibao Pharmaceutical Factory (Lanzhou Minshan Pharmaceutical Factory), China.


Serial Or Batch Number And Expiry Date:
All Batches


Recall Classification:
User Level.


Target Audience:
The General Public and Users of Traditional Chinese Medicinal Products.
Suppliers and Retailers of Traditional Chinese Medicinal Products.
Practitioners of Traditional Chinese Medicine Pharmacists.


Problem Or Issue:
Following the Safety Notification issued by the Irish Medicines Board (IMB) on the 24th August, 2007, concerning the presence of Xie Gan Wan Tablets, a potentially harmful aristolochic acid-containing Traditional Chinese Medicinal Product, in the UK marketplace, the IMB wishes to advise you that Xie Gan Wan Tablets have recently been identified in the Irish marketplace.  Three other potentially harmful Traditional Chinese Medicinal Products, Bai Tou Weng Wan Tablets, Chuan Xiong Cha Tiao Wan Tablets and Xiao Qin Long Wan Tablets have also been found in Ireland.   

Samples from the following batches of products obtained from the Irish market were analysed and found to contain varying levels of aristolochic acids:   

Xie Gan Wan Tablets, No batch number on sample tested, Manufactured/Distributed by Ekong International (UK) Ltd;   

Bai Tou Weng Wan Tablets, Batch Number 20021211, Manufactured by Lanzhou Taibao Pharmaceutical Factory, China, Distributed by Gansu Medicines & Health Products Import & Export Corporation Lanzhou, China;   

Chuan Xiong Cha Tiao Wan Tablets, Batch Number 20050704, Manufactured by Lanzhou Taibao Pharmaceutical Factory, China (Lanzhou Minshan Pharmaceutical Factory), Distributed by Gansu Medicines & Health Products Import & Export Corporation Lanzhou, China;   

Xiao Qin Long Wan Tablets, Batch Number 20050705, Manufactured by Lanzhou Taibao Pharmaceutical Factory, China (Lanzhou Minshan Pharmaceutical Factory), Distributed by Gansu Medicines & Health Products Import & Export Corporation Lanzhou, China.    

Aristolochic acids are a component of herbal plants of the genus Aristolochia, which is known to be toxic to the kidney and is regulated in Ireland as a prescription only substance.  Xie Gan Wan Tablets, Bai Tou Weng Wan Tablets, Chuan Xiong Cha Tiao Wan Tablets or Xiao Qin Long Wan Tablets are not authorised in Ireland as medicinal products.


Background Information Or Related Documents:
A Safety Notification was issued for Xie Gan Wan Tablets in August, 2007, (IMB Ref QDR-H07-335) to alert the general public, pharmacists and various trade groups of the possible presence of potentially harmful aristolochic acid-containing Xie Gan Wan Tablets, on the Irish market.  In Ireland, Longdan Xiegan Wan capsules were found in the Irish marketplace in 2006.  

This product was removed from the market at that time, and an alert was issued by the IMB on October 19th, 2006 in this regard.  

Potentially Harmful Traditional Chinese Medicinal Products Document


Actions To Be Taken:
Any patients or members of the public who are using, or have used, the above-mentioned products, are advised to immediately cease taking the product(s) and to consult with their pharmacist or doctor, even if they have stopped using the product(s).  When speaking to their doctor or pharmacist, patients or members of the public may find it helpful to take a copy of this IMB notification with them. Patients should continue to take any medication prescribed by their doctor.       

Any persons holding stock of these products, or who have supplied these products to others, or who may have packs of the products in their possession, should put the products in a safe place immediately and notify the IMB at the contact details below.      

The IMB is also alerting trade and other relevant organisations representing companies or individuals supplying, selling or using Traditional Chinese Medicinal Product today to advise them of this issue, so that their members can be made aware of this information as soon as possible.  In this regard, the IMB requests trade and other relevant organisations to bring the information in this Warning notice to the attention of their members, so that their members may cease supplying/selling/using these products, and contact the IMB. Any packs of the above-mentioned products should be immediately quarantined. The Irish Medicines Board is also requesting any retailers and suppliers of this product to try and contact their customers, so that they can be advised of the above.


Further Information:
Please note that there may be other versions of these products in the marketplace, (i.e. products with the same name and with similar packaging), and these products may also contain aristolochic acid. The IMB advises that such products may be harmful if consumed.  The IMB is continuing to monitor the marketplace for such products.  The IMB wishes to advise that vigilance should always be exercised in relation to the purchase, sale and/or use of any Traditional Chinese Medicinal Product that may contain, or that may be derived from, the herb the herb genus Aristolochia.    

The HPRA contact person for this issue is:   

Breda Gleeson, 
Market Compliance Inspector, 
Health Products Regulatory Authority, 
Earlsfort Terrace, 
Dublin 2, 
Ireland  
Tel:   +353-1-6764971 
Fax:  +353-1-6764061


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