Products found to contain undeclared medicines
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| The United States: SOS Telecom, Inc. recalls new unapproved drugs marked as dietary supplements |
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SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of Tiger-X, Ninja-X, Ginseng Power-X and Super Samurai-X to the consumer level because these products were tested by the FDA and found to contain sildenafil, and analogs of sildenafil. These products were marketed as dietary supplements for male sexual enhancement. The products were sold through numerous retailers, including convenience stores and gas stations.
Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. This undeclared active ingredient poses a threat to consumers because sildenafil 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. Additionally, the product may cause side effects, such as headaches and flushing.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm500801.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Friday, May 13, 2016
Issued at HKT 15:00
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