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Safety Notice:Concerning two Chinese Herbal Products which may contain Undeclared Prescription Active Pharmaceutical Ingredients
Notice type:
Advisory
Date:
15/06/2006
Product name or type:
Nasutra Capsules and Li Da (Dai Dai Hua Jiao Nang) Capsules
Reference:
2006
Active Substance:
Unknown
Product Classification:
Chinese Herbal Products
Target Audience:
Patients, wholesalers and distributors.
Problem Or Issue:
The Irish Medicines Board (IMB) has recently been informed by the New Zealand Medicines Agency that the following two Chinese Herbal Products may contain undeclared prescription active pharmaceutical ingredients:
Nasutra Capsules
:One batch of this product, batch number WP106 which expires in 01/2009, was found by the New Zealand Medicines Agency to contain undeclared sildenafil. Each capsule from this batch is reported to contain approximately 35mg sildenafil.
Li Da (Dai Dai Hua Jiao Nang) Capsules
: These capsules, which are manufactured by Kunming Dali Industry & Trade Company Ltd, China, were found by the New Zealand Medicines Agency to contain undeclared sibutramine. Each capsule is reported to contain approximately 15mg of sibutramine and all batches are reported to be affected.
While Ireland has not been identified as a market for Nasutra Capsules or Li Da (Dai Dai Hua Jiao Nang) Capsules, there is no conclusive evidence that such products are not on the market here. As a precautionary measure, the IMB has today communicated with various trade organisations about the issue, so that their members, who may be wholesaling, selling or using these products, can be made aware of this information.
The IMB requests anyone who is wholesaling, selling or using any of these products to quarantine any packs they have in their possession and to contact the IMB at the contact details shown below.
Background Information Or Related Documents:
Safety Notice:Concerning two Chinese Herbal Products which may contain Undeclared Prescription Active Pharmaceutical Ingredients Document
Actions To Be Taken:
Patients
who received any of these products from your members should be advised to cease taking the product in question and to consult with their pharmacist or doctor. When speaking to their doctor or pharmacist, patients may find it helpful to take a copy of this IMB notification with them. They should continue to take any medication prescribed by their doctor.
Further Information:
The HPRA contact person for this issue is:
Breda Gleeson,
Market Compliance Inspector,
Health Products Regulatory Authority,
Kevin O’Malley House,
Earlsfort Terrace,
Dublin 2,
Tel: +353 1 634 3331
Fax: +353 1 676 4061
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Date Printed: 19/04/2024