Products found to contain undeclared medicines
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| The United States: American Lifestyle Issues a Worldwide Voluntary Recall of Vicerex Capsules and Black Ant Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients Tadalafil or Sildenafil |
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The Food and Drug Administration (FDA) announced that American Lifestyle is conducting a voluntary recall of all lots of Vicerex and Black Ant. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. These undeclared active ingredients poses a threat to consumers because tadalafil and 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. No Adverse events have been reported related to this recall. Vicerex is sold in blister packs containing ten (10) capsules and Black Ant is sold in a box containing four (4) individually wrapped capsules. The product is distributed worldwide by American Lifestyle by on-line sales and retail. The products are being promoted for increasing desire and sexual performance and sold without medical prescription.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm350574.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Friday, May 03, 2013
Issued at HKT 12:00
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