Haute Health, LLC Conducts Voluntary Nationwide Recall of All Lots Of Virilis Pro, PHUK And Prolifta Capsules Due To Undeclared Ingredients

Date of Recall

2013-09-30

Recall Details

- September 24, 2013 - Williamstown, New Jersey - Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED). This issue was brought to our attention as a result of sample-testing conducted by the FDA.

Sildenafil has the potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, sildenafil may cause side effects, such as headaches and flushing. To date, however, there have been no reported adverse events associated with the presence of sildenafil in Virilis Pro, PHUK or Prolifta.

Virilis Pro, PHUK and Prolifta are labeled and intended to be used as dietary supplements for sexual enhancement. Virilis Pro is packaged in a 1 and 2 capsule blister packs and 10 capsule bottles. PHUK is packaged in 1 and 2 capsule blister packs and 4, 12, 24 capsule bottles. Prolifta is packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles. All three products are distributed nationwide to wholesale and retail customers and via the internet.

Aided with the information provided by the FDA, Haute Health, LLC is notifying its distributors and customers by an email and online notice on the homepage of our website http://www.virilispro.com of this voluntary recall. Although Haute Health, LLC has not yet determined whether unlisted sildenafil is contained in lots of dietary supplements not tested by the FDA, as a precaution, Haute Health, LLC is recalling all lots. Haute Health, LLC will arrange for a return of all recalled products. Consumers that have Virilis Pro, PHUK or Prolifta supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt. Retailers who have Virilis Pro, PHUK or Prolifta supplements should stop selling the product.

Consumers with questions regarding this voluntary recall can contact Michael Carney via email at [email protected] or by phone at 856-404-9474 from Monday to Friday, 11am to 5pm, EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Use postage-paid, pre-addressed Form FDA 3500 available
  at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of and at the request of the U.S. Food and Drug Administration.

Haute Health, LLC would like to ensure its customers that it takes the safety of its customers very seriously, and receives this product from the manufacturer in sealed packages and with a certificate of analysis that represents that the product contains only the lawful and legitimate listed ingredients. Haute Health, LLC is relying on the representations of the Food and Drug Administration that the public interest would best be served by voluntarily complying with their request to recall the product. "Our goal is to protect the safety of the consumer," stated Michael Carney, on behalf of Haute Health LLC, and "we will be working with our manufacturer to discover and correct the source of any unlisted ingredient."

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