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Monday, September 30, 2013
Nationwide Recall of All Lots of Virilis Pro, and Prolifta Capsules Due To Undeclared Ingredients
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 websitehttp://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.