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Lady products recalled: FDA finds Staphylococcus, benzocaine, unsubstantiated claims

Two highly questionable feminine products are being recalled by a Los Angeles-based company following the Federal Drug Administration discovery of Staphylococcus bacteria and other pathogens in one product, and the anesthetic benzocaine, in the other.

The products are sold to herbal stores, beauty shops and drug stores by an Alhambra-based company called USA Far Ocean Group Inc. (U.S.A. Far Ocean), that promotes the product with disturbing questions like, "Are you deeply concerned about female diseases?" and "Do you want to get rid of them forever and regain your charm?"

The products, sold also in stores, online and via mail order, are packaged individually as "Vagifresh Ball" and "Vagifresh Gel," and packaged together as "Female One." 

FDA lab analysis found that the Vagifresh Gel contained benzocaine, a local anesthetic commonly used as a topical pain reliever, while analysis of the Vagifresh Ball found bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp.

Additionally, the FDA determined that product descriptions and marketing materials for the products contained "unsubstantiated therapeutic claims," and could have kept women from seeking critical medical care for serious medical conditions.

According to a website selling Feminine One, the "Ten Major Functions" of the products include, "cleanse the female reproductive system," and regulate secretions, as well as tighten, improve desire, eliminate disease, relieve endometriosis, and improve acne. But only for non-virgins.

It really says that.

Below the wildly unsubstantiated claims, the site details product-use, including instructions like, "allow the ball to remain in the vagina for 48 hours." A graphic list of symptoms a woman might expect during "the course of detoxification," follows.

Following products are involved in this voluntary recall:

  • Vagifresh Ball, 3 tablets, individual pack/packed with Female One, 689076499156
  • Vagifresh Gel, 2 fl.oz. tube, individual pack/Packed with Female One, 689076499057

All lots of the listed products are affected by this recall.

The FDA reports that U.S.A. Far Ocean is taking necessary steps to contact wholesalers, retailers and customers for the return of these products. Consumers in possession of these products should stop using it immediately, and are advised to contact their physician. Any unused products should be returned to their immediate supplier for a direct refund.

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