Products found to contain undeclared medicines
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| The United States: Organic Herbal Supply, Inc. announces a voluntary nationwide recall of XtraHRD Natural Male Enhancement Capsule |
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Organic Herbal Supply, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product. To date, no adverse events have been reported.
XtraHRD Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. It is packaged in 2, 4 and 10 count packages and sold nationwide.
Use of this product 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 XtraHRD 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/ucm542499.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the US FDA, and was posted on the Drug Office website on 27 January 2017.
Ends/ Wednesday, February 22, 2017
Issued at HKT 13:00
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