Products found to contain undeclared medicines
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| The United States: Virilis Pro, PHUK and Prolifta Capsules: Recall - Undeclared Ingredient Sildenafil |
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The US Food and Drug Administration (FDA) announced that 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). 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. 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. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm370587.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Wednesday, October 02, 2013
Issued at HKT 12:00
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