(WTXL) - USA Far Ocean Group Inc. is notifying the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics.
Vagifresh Ball and Vagifresh Gel products are marketed as cosmetics, and applied by inserting deeply into the vagina for a prolonged period of time.
Vagifresh Gel was found by FDA analysis to contain benzocaine, an active ingredient for many anesthetic drug products. FDA analysis of Vagifresh Ball found the product contains bacteria,
including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp. 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.
Consumers in possession of these products should stop using it immediately and contact their physician if they experienced any problem that may be related to using any 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: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
