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Beline Capsules

Notice type: Warning

Date: 23/06/2011

  

Product name or type:
Beline Capsules

Reference:
QDR-H-11-502

Authorisation Number:
None - This is not an authorised medicine

Active Substance:
Stated on the labelling as various herbal ingredients, but found to contain chlorphenamine, piroxicam and oxetacaine.

Manufacturer Or Supplier:
Manufacturer unknown. Supplied to Europe by FocusHR Limited, Shropshire, UK

Serial Or Batch Number And Expiry Date:
All batches.

Recall Classification:
Patient Level

Target Audience:
The General Public
Retailers of Herbal Medicines
Healthcare Professionals

Problem Or Issue:

The Irish Medicines Board (IMB) wishes to advise the general public, retailers of herbal medicines and healthcare professionals that samples of the herbal product Beline capsules have been found to be adulterated with medicines, including prescription-only substances. The capsules, when tested, were found to contain the following medicines:

·         Chlorphenamine, an antihistamine

·         Piroxicam, a non-steroidal anti-inflammatory drug (NSAID)

·         Oxetacaine (also known as oxethazine), a local anaesthetic

 

Products containing these medicines require a medicinal product authorisation in order to be legally sold on the Irish market.

These medicines are not indicated on the product labelling as being present and they render this product to be an illegal medicine. Beline capsules are not authorised for marketing in Ireland and cannot be considered safe.

Products containing piroxicam or oxetacaine cannot legally be sold in Ireland without a prescription, while the sale of chlorphenamine-containing products is confined to pharmacies only. Beline capsules are available for purchase over the internet and it is illegal to sell this product over the internet to customers in Ireland.

Background Information Or Related Documents:

Beline capsules can come in a brown or green box with white text. The capsules are dark green in colour.

Please see below links to images of the product

Beline Capsules 1.jpg

Beline Capsules 2.JPG

Beline Capsules Document

Actions To Be Taken:
Any retailers of herbal medicinal products who have Beline capsules in their possession should immediately quarantine the stock and notify the Market Compliance Section of 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 contacted.

Any persons, other than retailers, who are in possession of Beline capsules should dispose of the stock safely. In addition, we ask that individuals who have purchased this product contact the IMB Enforcement Section at the contact details below.

Any patients or members of the public who are using, or have used, Beline Capsules are advised to consult their pharmacist or doctor, even if they are no longer taking the product. When consulting their doctor or pharmacist, patients may find it useful to take a copy of this notification with them.

Further Information:

The HPRA contact persons for this issue are:

Market Compliance Section

Ms. Aoife Farrell, 
Quality Defects and Recall Manager, 
Health Products Regulatory Authority, 
Earlsfort Terrace, 
Dublin 2, 
Ireland   
Tel:   +353-1-6764971 (office) 
Fax:  +353-1-6764061
Mobile: +353-86-0249808

recallsandqualitydefects@imb.ie


Enforcement Section

Health Products Regulatory Authority, 
Earlsfort Terrace, 
Dublin 2, 
Ireland   
Tel:   +353-1-6343436 (office) 
Fax:  +353-1-6764061

enforcement@imb.ie

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