Vagifresh products have been recalled for an undeclared drug ingredient and bacterial contamination, according to the U.S. Food and Drug Administration (FDA).
USA Far Ocean Group Inc. announced that it is recalling its Vagifresh Ball and Vagifresh Gel; both products are sold as cosmetics. FDA analysis revealed that Vagifresh Gel contains benzocaine, an active ingredient found in many anesthetic drug products. Analysis also revealed that the Vagifresh Ball contains multiple bacteria: Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.
The FDA said it has also determined that marketing material for the Vagifresh Gel and Vagifresh Ball products contained unsubstantiated therapeutic claims related to various gynecologic conditions. This, said the FDA, could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.
Vagifresh Ball and Vagifresh Gel products, which are marketed as cosmetics, are applied by inserting the product deeply into the vagina for a prolonged period of time. These products were sold in herbal stores, beauty shops, drug stores, and on the Internet and via mail order.
Both the Vagifresh Ball and Vagifresh Gel were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel, and Vagifresh Liquid. This recall does not include the Vagifresh Liquid product.
Consumers in possession of these products are advised to stop using the products immediately and to contact their physicians if they experienced any problem that may be related to use of 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: Complete and submit the report Online at www.fda.gov/MedWatch/report.htm; download the reporting form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1.800.332.1088, toll-free, to request a reporting form, which should be completed and returned to the address indicated on the form; or submit the form by toll-free fax to 1.800.FDA.0178.