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Li Da Dai Dai Hua Capsules
Notice type:
Warning
Date:
22/09/2008
Product name or type:
Li Da Dai Dai Hua Capsules
Reference:
HPRA Reference: QDR-H-08-375
Authorisation Number:
None
Active Substance:
Some packs of this product were found to contain Sibutramine Hydrochloride, and others were found to contain a related substance known as Desmethyl-Sibutramine.
Manufacturer Or Supplier:
Manufactured by:
Kunming Dali
Industry & Trade Co. Ltd.,
No. 372 West Renmin Road,
Kunming, Yuman,
China.
Suppliers unconfirmed.
Serial Or Batch Number And Expiry Date:
Serial/Batch Number(s):
All batches
Expiry Date:
Various
Recall Classification:
Recall Required:
Yes (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:
Further to the communication issued by the Irish Medicines Board (IMB) in July, 2008, concerning Li Da Dai Dai Hua Capsules, a potentially harmful and illegal medicinal product, the IMB wishes to provide you with the following new information.
A number of samples of Li Da Dai Dai Hua Capsules obtained from the Irish marketplace have been analysed by the IMB. Some of the capsules analysed were found to contain Sibutramine Hydrochloride, and others were found to contain a related substance known as Desmethyl-Sibutramine. These laboratory results mean that packs of Li Da Dai Dai Hua Capsules on the Irish market have been found to be adulterated with a prescription only-substance. This product is an illegal medicinal product which has not been authorised for marketing in Ireland and cannot be considered as suitable for consumption due to potential safety concerns.
Background Information Or Related Documents:
The following information is intended to be helpful in identifying the products of concern:
• This product is packaged in capsule form.
• The capsules are green in colour, and are contained within a blister-strip.
• The blister strip is silver in colour, with blue and purple Chinese markings.
• The blister strip is contained with an aqua-green coloured cardboard box, showing a picture on the front cover of a female behind a newspaper.
Click here to read the
Finalised Letter to Trade and Professional Bodies 18-09-08
Related Photographs of the product in question:
Blister Strip
Capsule
Lida Outer Carton Market Compliance Sample
Lida Outer Carton Market Compliance Sample 2
Li Da Dai Dai Hua Capsules Document
Actions To Be Taken:
Any patients or members of the public who are using, or have used Li Da Dai Dai Hua Capsules, are advised to immediately cease taking that product and to consult with their pharmacist or doctor if they have any concerns. When speaking with their doctor or pharmacist, they may find it helpful to take a copy of this IMB notification with them. This can be downloaded from the website at
www.hpra.ie
.
Any persons holding stock of the above product should put the packs 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 Products 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 this product, and contact the IMB. Any packs of this product should be immediately quarantined.
The Irish Medicines Board is also requesting any retailers and suppliers of these products to contact their customers, where possible, so that they can be advised of the above.
Any suspected adverse reactions associated with use of Li Da Dai Dai Hua Capsules should be notified to the IMB, via the on-line reporting system accessible from
www.hpra.ie
and by following the link to ‘on-line reporting’. A downloadable report form is also available from the website.
The IMB wishes to advise that vigilance should always be exercised in relation to the purchase, sale and/or use of any medicinal product, including Traditional Chinese Medicinal Products. Medicinal products such as the above product are not authorised for use in Ireland, and cannot be regarded as safe. These types of products are illegal medicines and should not be purchased for use over the internet.
Further Information:
The HPRA contact person for this issue is:
Kevin O' Donnell, Ph.D.
Senior Inspector & Market Compliance Manager,
Health Products Regulatory Authority,
Earlsfort Terrace,
Dublin 2,
Ireland
Tel: +353-1-6764971
Fax: +353-1-6764061
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Date Printed: 12/05/2024