Vagifresh Ball, Vagifresh Gel, and Female One - Products Recalled
January 23, 2012
US Far Ocean Group, Inc. has recalled all lots of Vagifresh Ball and Vagifresh Gel products. FDA analyses discovered bacteria in Vagifresh Ball and benzocaine in Vagifresh Gel. Benzocaine is an ingredient that was not declared to FDA. FDA also found unsubstantiated marketing claims regarding the therapeutic effects of these products. These claims could lead women with serious medical conditions to fail to seek appropriate medical treatment. Vagifresh Ball and Vagifresh Gel were sold as cosmetics and were administered vaginally.
Vagifresh Ball and Vagifresh Gel were also sold in a combination package with Vagifresh Liquid under the name Female One. The products were available by mail order, on the internet, and in herbal stores, beauty shops, and drug stores. Bacteria discovered in Vagifresh Ball included various Staphylococcus, Bacillus, Alloiococcus, Aerococcus, Aeromonas, Gemella, and Leuconostoc spp. The manufacturer has not received reports of adverse effects related to either the bacterial contamination or the presence of benzocaine in these products at the time of the recall.
Stop use of Vagifresh Ball (UPC code 689076499156) and Vagifresh Gel (UPC code 689076499057) immediately. Persons who have used these products are advised to consult a healthcare professional if they experience any adverse effects associated with use of these products. Report adverse events related to recalled products to Medwatch Safety Information and Adverse Event Reporting Program. Consumers may return Vagifresh Ball, Vagifresh Gel, and Female One to the place of purchase for a refund. For any questions regarding the return of these products, consumers may call the company at 626-560-2435.
For additional information see the following links:
- MedWatch safety alert
- Firm Press Release
- Photographs of recalled products
January 23, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.