Female One, Vagifresh Gel, Vagifresh Ball Recall For Unconfirmed Drug and Bacterial Contamination

Consumers and OB/GYN have been alerted by the USA Far Ocean Group Inc. and through the FDA of the recall affecting the following products:

• Female One
• Vagifresh Gel
• Vagifresh Ball

Background of the recalled products

Two of the recalled products, Vagifresh Gel and Vagifresh Ball, are cosmetic products that are administered by inserting them deep inside a woman’s vagina where the product should stay for a long duration after its application.

The connection is that both Vagifresh Gel and Vagifresh Ball (together with Vagifresh Liquid—which was not affected by the recall) are sold as a combination packed and branded as Female One.

Distribution networks for the said products include:

• Beauty department stores
• Chemists
• Herbal retail outlets
• Online shops
• Mail order

FDA Issue

In an evaluation conducted by the FDA on the recalled products, the following issues were raised:

Traces of an unconfirmed drug component:

• The FDA identified that the active ingredient, Benzocaine, was present in Vagifresh Gel
• Benzocaine is found in various anesthetic drugs

Presence of bacterial contagions:

• The FDA found that Vagifresh Ball was contaminated by the following bacteria:
  • Aerococcus viridans
  • S. sciuri
  • Aeromonas salmonicid
  • Alloiococcus otitis
  • Gemella spp
  • Bacillus Lantus
  • Leuconostoc spp.
  • Staphylococcus lentus

Misleading marketing strategy

• The FDA also has issue with the marketing strategy employed for the 3 products recalled
• Some of the marketing campaigns highlighted uncorroborated medicinal claims
• Certain claims associated with gynecological cases would encourage female consumers using the products not to seek medical advice from a health professional
• This would result in adverse medical conditions going unattended to, thereby risking the woman’s health

FDA Recommendation

“ 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. ”

Contacting the FDA to report cases relating to Vagifresh and Female One

• Any adverse side effects or incidences relating to the use of Vagifresh products (Vagifresh Ball and Vagifresh Gel) and Female One from the USA Far Ocean Group Inc. should immediately be reported to the FDA.
• This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:
• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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