Products found to contain undeclared medicines
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| The United States: Vitality Research Labs, LLC, Issues Immediate Voluntary Nationwide Recall of "VitaliKOR Fast Acting" Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients Vardenafil and Tadalafil |
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The US Food and Drug Administration (FDA) announced that Vitality Research Labs, LLC, the repackager of the VitaliKOR Products, is voluntarily recalling lots K58Q and F50Q of VitaliKOR Fast Acting to the consumer level. FDA laboratory analysis on VitaliKOR has determined that this product contains undeclared Vardenafil and Tadalafil.
Vardenafil and Tadalafil are active ingredients of FDA-approved drugs used to treat erectile dysfunction (ED), making VitaliKOR Fast Acting an unapproved drug. The undeclared active ingredients poses a threat to consumers because Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe 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.
This product is marketed as an all-natural nutritional supplement for sexual enhancement and packaged in chip board exterior carton containing clear plastic bottles with forty (40) light blue capsules and were sold nationwide through various internet websites and at retail stores. The number of individual units affected by the recall is 66,090. The lots were produced in January and July of 2013.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm375104.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by FDA and was posted on the Drug Office website on 11 November 2013.
Ends/ Friday, November 15, 2013
Issued at HKT 14:00
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