EFFECT OF MICROBIAL CONTAMINATION DIFFICULT TO ASSESS
COMMENT
USA Far Ocean Group issued a voluntary recall following FDA’s laboratory analyses of “Vagifresh Gel” and “Vagifresh Ball”. The former contained benzocaine, while the later contained bacteria from a number of species to include Staphylococcus lentus, S. sciuri, Bacillus lentus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp. Many of the isolated bacteria are readily isolated from the soil and animal wastes. Ironically, Aeromonas salmonicid was first isolated from salmonids (salmon). The FDA advised that the bacterial contamination would be difficult to assess. However, the presence of these microorganisms suggest that the facilities were not maintained under cGMP based on the variety of the “bugs” present. Also, because the product is inserted “deeply into the vagina”, it remains possible that if substantial numbers, e.g., log quantities of any of these “bugs” might be present, they would create an irritation if not worse. Please also see recent issues with Triad Group (see my historic Blogs on Triad Group) who was selling a “sterile” cream for PAP testing that was deemed not sterile.
USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall
of Vagifresh Ball and Vagifresh Gel , Marketed Individually or
Under a Mixed Package Named Female One
Contact:
Consumer:
Special Service Department
626-560-2435
FOR IMMEDIATE RELEASE – January 18, 2012 – USA Far Ocean Group Inc. (U.S.A. Far Ocean), is voluntarily recalling the Company’s two products sold as cosmetic under the names 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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. U.S.A. Far Ocean is taking necessary steps to contact wholesalers, retailers and customers for the return of these products. 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.
Consumers in possession of products should also return any unused products to their immediate supplier for a direct refund. Customers with questions 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.
U.S.A. Far Ocean is committed to providing our customers with high quality, pure and safe products. We are investigating the root cause in the manufacturing processes that has lead to this voluntary recall. We are taking every measure to ensure the quality and purity of any product made by our manufacturers so that this will never happen again in the future. We are extremely sorry and hope that you will not lose faith in our brand.
Any adverse reactions or quality problems experienced with the use of any of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: http://www.fda.gov/MedWatch/report.htm1
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2.
- Fax: 1-800-FDA-0178
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