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Magicream

Notice type: Warning

Date: 18/02/2014

   

Product name or type:
Magicream

Reference:
QDR-H-13-654

Authorisation Number:
None - This is not an authorised medicine

Active Substance:
The package leaflet states that the product is formulated from natural ingredients, but the Irish Medicines Board's analysis found three active ingredients that are not stated on the labelling or package leaflet 

Manufacturer Or Supplier:
Unknown at this time

Serial Or Batch Number And Expiry Date:
All batches are considered potentally affected by this issue

Recall Classification:
Patient Level

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

Problem Or Issue:
The Irish Medicines Board wishes to advise the general public, healthcare professionals and users and retailers of Herbal Medicines that a sample of the product known as Magicream has been found to be adulterated with three active ingredients.

The sample, when tested by an independent laboratory for the IMB, contained the active ingredients Betamethasone-21-Valerate, Betamethasone-17-Valerate and Ketoconazole.

Betamethasone is a steroid and ketoconazole is an antifungal used to treat infections caused by fungi or yeasts. Products containing these active ingredients require an authorisation in order to be legally sold on the Irish market. These active ingredients are not declared on the Magicream product labelling and they render this product to be an illegal medicine. Magicream is not authorised for marketing in Ireland and it cannot be considered safe.

The IMB is aware that Magicream has been available for purchase over the internet but it is illegal to sell this product over the internet to customers in Ireland.

Please note that Magicream had previously been tested on behalf of the IMB in January 2011. At that time, it was found to contain two active ingredients: ketoconazole, as above and clobetasol propionate, which is a different steroid to the one identified in the more recent testing. At that time, the Irish Medicines Board issued an alert to the general public, healthcare professionals and users and retailers of Herbal Medicines, advising that this product should not be used. Here is a link to the IMB's 2011 alert:

Magicream 2011 Alert

Background Information Or Related Documents:
Magicream comes in a small, white, 30ml tub. The tub bears a yellow label with green text and the name of the product on the tub is 'Magicream' 

Magicream Document

Actions To Be Taken:
  • Retailers of Herbal Medicines: Any retailers who have Magicream in their possession should immediately quarantine the stock and notify 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. 
  • Healthcare Professionals and other persons in possession of Magicream: Anyone in possession of Magicream should place the stock in a safe place and immediately contact the IMB, at the details below
  • Patients or other Members of the Public: Any patients or other members of the public who are using, or have used, Magicream are advised to immediately stop using this product. They should consult their phamacist or doctor, even if they have already stopped taking the product. When consulting their pharmacist or doctor, patients may find it useful to take a copy of this notification with them.

Further Information:
The HPRA contact for this issue is:

Kevin O'Donnell, PhD,
Market Compliance Manager
Health Products Regulatory Authority | An tÚdarás Rialála Táirgi Sláinte
Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6764061
kevin.odonnell@hpra.ie
www.hpra.ie

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