November 18, 2013
Vitality Research Labs, LLC, Recalls "VitaliKOR Fast Acting" Marketed as a Dietary Supplement
The Missouri Department of Health and Senior Services received information regarding a recall of lots K58Q and F50Q of VitaliKOR Fast Acting. The 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. The product was sold nationwide through the internet and at retail stores.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm375104.htm.