USA Far Ocean Group has recalled its "Vagifresh Ball" and "Vagifresh Gel," because the Food and Drug Administration found bacteria in the products.

In addition, the FDA determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products to not seek appropriate medical care for potentially serious medical conditions.

Vagifresh Ball and Vagifresh Gel products are marketed as cosmetics, and applied by inserting deeply into the vagina for a prolonged period of time.

The recalled products contain benzocaine, an active ingredient for many anesthetic drug products. 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.

Recalled products are:

• Vagifresh Ball: Three tablets (individual pack or packed with Female One), UPC 689076499156.


• Vagifresh Gel: 2 fluid ounces (individual pack or packed with Female One), UPC 689076499057.

These products were sold at herbal stores, beauty shops, drug stores, as well as on the Internet and by mail order, and were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid).

FDA analysis of Vagifresh Ball found the product contains bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

Consumers in possession of these products should stop using them immediately and contact their physician if they experienced any problem that may be related to using any of these products.

No illnesses have been reported to the Company to date in connection with these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of Vagifresh Ball and Vagifresh Gel, Marketed Individually or Under a Mixed Package Named Female One [FDA]