News Releases

January 20, 2012

USA Far Ocean Group Issues Voluntary Recall to Vagifresh Ball and Vagifresh Gel Products

The Missouri Department of Health and Senior Services received the following recall regarding two products sold as cosmetic under the names Vagifresh Ball and Vagifresh Gel.

These products were also sold under the mixed package named Female One. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Vagifresh Gel sample found the product contains benzocaine, the active ingredient for many anesthetic drug products. In addition, FDA analysis of Vagifresh Ball sample found the product contains bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp.

The effect of the absorption of the amount of Benzocaine contained in Vagifresh Gel is unknown, but there is the possibility of an adverse reaction or unknown drug-drug interaction. The effect of the bacterial contamination in VagiFresh Ball is unknown and difficult to assess.  No illnesses have been reported to the Company to date in connection with these products.  The FDA has also determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

The full recall announcement can be found at: http://www.fda.gov/Safety/Recalls/ucm288260.htm?source=govdelivery

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