Products found to contain undeclared medicines
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| The United States: Organic Herbal Supply issue voluntary nationwide recall of all lots of various supplements for male and female sexual enhancement due to undeclared tadalafil and flibanserin |
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Organic Herbal Supply, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. The U.S. Food and Drug Administration (FDA) analysis has found the products to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED), the presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these two products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. There have been no reports of illness to date.
Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. They are packaged in 2, 4 and 10 count packages and sold nationwide. Zrect for women and LabidaMAX were packaged in 30 count packages and sold nationwide through Amazon.com and through Zrect.com. Organic Herbal began shipping this product on or around December 2014 through February 2017.
Use of these products may pose a threat to consumers because the undeclared active ingredients 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Organic Herbal Supply, advises any customers in possession of the above products to stop using and return any unused product for a full refund to the company directly. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm553631.htm
In Hong Kong, the above products are not registered pharmaceutical products, and there is no registered pharmaceutical product manufactured by Organic Herbal Supply, Inc., U.S.
Ends/Wednesday, April 19, 2017
Issued at HKT 15:00
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