The FDA has announced today the recall of Vagifresh Ball and Vagifresh Gel. An analysis by the FDA has found that Vagifresh Gel contains benzocaine, an active ingredient for many anesthetic drug products. An analysis of Vagifresh Ball found the product to contain bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicida, Gemella spp, and Leuconostoc app.
The FDA has further determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women to take these products instead of seeking appropriate medical care for potentially serious medical conditions.
These products, marketed as cosmetics, are applied by inserting deeply into the vagina for a prolonged period of time. Sold in herbal stores, beauty shops, drug stores, the internet, and by mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel, and Vagifresh Liquid, though this recall does not involve Vagifresh liquid.
Consumers are being instructed to immediately stop using the products and contact their physician if they experienced any problem that may be related to their use.
I’m a man. It is not exactly comfortable putting this kind of information out there. But when safety is at issue, you really have to put that kinda stuff aside.