Lot Number 10090571
FOR IMMEDIATE RELEASE - November 10, 2011 - Keime Incorporated announced today that it is conducting a voluntary recall of one lot of the companies dietary supplement product sold under the following name: Virility Max. The company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug.
The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
Virility Max is used for sexual enhancement. It is distributed in 10 count, white plastic bottles to retail customers in the South Florida area.
No illnesses have been reported to the company to date in connection with this product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online [at www.fda.gov/MedWatch/report.htm
Rebular Mail; use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm
Keime Inc., a Florida Corporation, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. This product was purchased from others and not manufactured by Keime Inc. Keime Inc. is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers should return any unused product to the retail location where they were purchased or contact Keime Inc. directly at 561-368-2070 Monday – Friday, 9 AM to 5 PM EDT.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration
Source: U.S. Food and Drug Administration
Sulfoaildenafil (thioaildenafil) is a synthetic chemical compound that is a structural analog of sildenafil (Viagra). It was first reported in 2005, and it is not approved by any health regulation agency. Like sildenafil, sulfoaildenafil is a phosphodiesterase type 5 inhibitor.
Sulfoaildenafil has been found as an adulterant in a variety of supplements which are sold as "natural" or "herbal" sexual enhancement products. A range of designer analogues of USA FDA-approved inhibitors of type-5 cGMP-specific phosphodiesterase (PDE5), such as sildenafil and vardenafil, have been detected in recent years as adulturants in over-the-counter herbal aphrodisiac products and dietary supplements, in an apparent attempt to circumvent both the legal restrictions on sale of erectile dysfunction drugs, which are prescription-only medicines in most Western countries, and the patent protection which prevents sale of these drugs by competitors except under license to their inventors. These compounds have been demonstrated to display PDE5 inhibitory activity in vitro and presumably have similar effects when consumed, but have undergone no formal testing in either humans or animals, and as such represent a significant health risk to consumers of these products due to their unknown safety profile. Some attempts have been made to ban these drugs as unlicensed medicines, but progress has been slow so far, as even in those jurisdictions which have laws targeting designer drugs, the laws are drafted to ban analogues of illegal drugs of abuse, rather than analogues of prescription medicines. However at least one court case has resulted in a product being taken off the market.
In December 2010, the United States Food and Drug Administration (FDA) issued a warning to consumers about such products stating, "The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients."