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CAFIA ordered to withdraw the supportive preparation VASOGEN from circulation

01/13/2004
 

Czech Agriculture and Food Inspection Authority (CAFIA) ordered  to immediately withdraw the VASOGEN preparation with date of  usable life of  15.11.2005 from circulation. This freely available preparation  provably contains  „sildenafil“, which is pharmacologically effective substance and  must not be used without  medical prescription.  Sildenafil, that can be, under certain circumstances, a threat to consumer´s health, is not declared in  VASOGEN, even though, according to the State Institute for Drug Control, this substance has a lot of contraindications, for example cardiovascular disorders, heart attack,  strokes or  serious liver disorders, etc.  Therefore the preparation cannot be used with any medical exam. In addition to this, CAFIA have found out further differences in labelling of this product.

VASOGEN produced by American company  Ultra Health Products Inc., is imported to the Czech Republic by P.A.A. Agency  s.r.o. and is put into circulation as a food additive for support of sexual functions.

According to the current findings of CAFIA, there are only two batches of VASOGEN in circulation, of which that one, labelled with the date of usable life of  15.11.2005, provably contains sildenafil.
CAFIA then ordered to the importer to withdraw it immediately from circulation and to publish information about undesirable impacts of VASOGEN on its own web sites and also wherever this preparation has been sold. Concerning the second batch, the importer is obliged to provide information about ingredients to CAFIA. The importer is also obliged to inform quickly about every further delivery of this product. CAFIA has also given a report to Rapid Alert Systém for Food and Feed (RASFF) about this finding, who  warns control organizations of all EU countries.

On the basis of information from the American Food and Drug Administration /FDA/, this undeclared „sildenafil“ has been also found out   in a food additive named VINAROL , sold in USA. It was produced by the Ultra Health Products Inc., as well. But after inspection of FDA they have willingly withdrawn it from circulation. 

CAFIA warn consumers of possible health hazard and recommend consultations with doctors.

Photo: View of product (front, back and site) and fly sheets.


Author: RNDr. Daniela Kolejková - 55344 CSc. - Czech Agriculture and Food Inspection Authority