Recall -- Firm Press Release
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Vitality Research Labs, LLC, Issues Immediate Voluntary Nationwide Recall of "VitaliKOR Fast Acting" Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients
FOR IMMEDIATE RELEASE - November 13, 2013 – 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 bl ood 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. Vitality Research Labs has discontinued distribution and sales of these lots.
Consumers should not consume these lots of VitaliKOR Fast Acting and should return the products immediately to the place of purchase for credit. Vitality Research Labs, LLC is notifying its distributors and consumers by email and is arranging for credit of the entire recalled product. Consumers/distributors/retailers that have VitaliKOR for the lots identified for recall should return to place of purchase.
Consumers with questions regarding this recall should contact Vitality Research Labs at 1-855-424-1954 or via e-mail at customercare@vitalikor Monday - Friday, 8:30 am - 5:00 pm, PST. 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500
available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall action is being conducted with the knowledge of the U.S. Food and Drug Administration.
Photo: Product Labels
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.