Vagifresh Ball and Gel Recalled by USA Far Ocean Group Due to Contaminants
USA Far Ocean Group Inc. recently announced a recall of Vagifresh Ball and Vagifresh Gel. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid). Vagifresh Ball and Vagifresh Gel products are applied by inserting deeply into the vagina for a prolonged period of time. The company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Vagifresh Gel sample found the product contains benzocaine, the active ingredient for many anesthetic drug products. In addition, FDA analysis of Vagifresh Ball sample found the product contains bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp.
The effect of the absorption of the amount of Benzocaine contained in Vagifresh Gel is unknown, but there is the possibility of an adverse reaction or unknown drug-drug interaction. The effect of the bacterial contamination in VagiFresh Ball is unknown and difficult to assess. No illnesses have been reported to the Company to date in connection with these products. The FDA has also determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.
The following products are involved in this voluntary recall:
|Product||Package Size||UPC Codes|
|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. These products were sold via herbal stores, beauty shops, drug stores, internet and mail order.
According to the recall notice, consumers should stop using it immediately and contact their physician if they experienced any problem that may be related to using any of these products, and also return any unused products to their immediate supplier for a direct refund. Consumers with questions regarding this voluntary recall can call USA Far Ocean Group, Inc. at 626-560-2435 Monday through Sunday between 9 a.m. and 5 p.m. (PST) for further instructions or information with respect to the return and refund process.
If you have suffered an injury due to a contaminated health care product, a defective products attorney may be able to help you pursue the compensation you deserve. For more information, call 1-888-BURNETTI.