AUDIENCE: Consumer, Health Professional
ISSUE: Vitality Research Labs is recalling lots K58Q and F50Q of VitaliKOR Fast Acting. 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.
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.
BACKGROUND: VitaliKOR Fast Acting is marketed as an all-natural nutritional supplement for sexual enhancement. The number of individual units affected by the recall is 66,090. The lots were produced in January and July of 2013. Vitality Research Labs has discontinued distribution and sales of these lots.
RECOMMENDATION: Consumers should not consume these lots and should should contact Vitality Research Labs at 1-855-424-1954 Monday - Friday, 8:30 am - 5:00 pm, PST with any questions regarding this recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this unapproved drug. Consumers, distributors and retailers should return the lots identified to the place of purchase for credit.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/13/2013 - Firm Press Release - Vitality Research Labs, LLC]