Vagifresh Recall: Unapproved Drug and Bacterial Contamination
Due to a risk of bacterial infection and the use of unapproved drugs, a recall has been issued for some Vagifresh feminine hygiene products.
The Vagifresh recall was announced by the FDA on January 18, after federal regulators tested the allegedly homeopathic products.
The FDA found that not only did the Vagifresh Gel and Vagifresh Ball contain the anesthetic benzocaine, but samples also contained a host of potentially infectious bacteria in the Vagifresh Ball.
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Bacteria detected in the Vagifresh Ball included Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.
Both the ball and gel are supposed to be inserted into the vagina for a long period of time. According to the manufacturer, USA Far Ocean Group Inc., the effect of the drug and the bacteria is difficult to determine. The company says it has received no reports of illnesses connected to the product.
FDA investigators also determined that the company’s marketing of Vagifresh products contained unsubstantiated therapeutic claims related to gynecologic conditions. The agency says that the claims could lead to women taking the product instead of seeking appropriate medical care for conditions which could be serious.
The Vagifresh Ball, Gel and Liquid are sold together in a package labeled “Female One Series.” Only the Vagifresh Ball and Gel are affected by the recall. The Female One package includes three Vagifresh Ball tablets with UPC Code 689076499156 and a 2 fl. oz. tube of Vagifresh Gel with UPC Code 689076499057.
The Female One Series packages were sold in herbal stores, drug stores, beauty shops and through the internet and mail orders. Some internet sites sell the balls and gels separately. Prices online for the Female One Series package ranged from about $110 to $170.
USA Far Ocean and the FDA recommend that consumers stop using the products immediately and return any unused product to the place of purchase for a refund. Customers with questions can call USA Far Ocean at (626) 560-2435.
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