My HPRA: Register

Safety Notice Concerning a Chinese Herbal Medicinal Product, Mr. Dragon Capsules

Notice type: Warning

Date: 06/10/2006

  

Product name or type:
Chinese Herbal Medicinal Product, Mr. Dragon Capsules

Active Substance:
Unknown

Manufacturer Or Supplier:
Unknown

Serial Or Batch Number And Expiry Date:
All batches

Target Audience:
Wholesalers, distributors and patients

Problem Or Issue:
The Irish Medicines Board (IMB) has identified that packs of the Chinese Herbal Medicinal Product, Mr. Dragon Capsules, may contain an undeclared prescription active pharmaceutical ingredient. 

One batch of this product (batch number not identifiable), was tested by the UK Medicines Healthcare Regulatory Agency (MHRA), on behalf of the IMB. MHRA’s analysis concluded that the units tested were found to contain undeclared sildenafil at a concentration of 62-64mg per capsule. The presence of sildenafil in these packs renders them an unauthorised medicinal product. 

Mr. Dragon Capsules have been found on the Irish market. We do not have any information with respect to the manufacture of this product. 

In addition, the units identified on the Irish market did not carry a batch number. The capsules, which are red in colour, are packaged in blister format and there are three capsules per blister strip. Each blister strip is contained in an outer carton, and two of these cartons are presented in a cardboard sleeve, and promoted as a six capsule pack. 

Background Information Or Related Documents:
Safety Notice Concerning a Chinese Herbal Medicinal Product, Mr. Dragon Capsules Document

Actions To Be Taken:
The IMB requests anyone who is wholesaling, selling or using this product to quarantine any packs of the product which they have in their possession, and to contact the IMB at the contact details shown below.  Patients who received this product are advised to cease taking the product 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 

« Back