Products found to contain undeclared medicines
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| The United States: Super Power: Recall - contains undeclared ingredient sildenafil |
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Freedom Trading is conducting a voluntary consumer recall of a product sold as a dietary supplement under the brand name of Super Power. This product was sold between August 2012 and January 2013 nationwide. Analytical tests conducted by independent labs of Super Power concluded that the products contained trace amounts of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED) making this product an unapproved new drug. This undeclared active ingredient poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and 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 they may seek products to enhance sexual performance. Additionally sildenafil may cause side effects such as, headaches and flushing.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm337131.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, January 29, 2013
Issued at HKT 12:30
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