RECALL: Vitality capsules male enhancement dietary supplement may be life threatening

Vitality capsules wrongly marketed as a male enhancement dietary supplement containes sildenafil and tadalafil which is for treatment of male erectile dysfunction and can be life threatening to some male adults. One Source Nutrition is voluntarily recalling all lots of Vitality capsules.

Consumption of products with undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

FDA analysis has found the product tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil and tadalafil cannot be marketed as dietary supplements Vitality capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

To date, One Source Nutrition, Inc. has not received any reports of adverse events related to this recall.

The tainted Vitality capsules marketed as a dietary supplement used as a male enhancement product is packaged in a single pill. The affected Vitality capsules product does not have lot numbers or expiration dates. The product can be identified by a single pill in an orange and gray package with blue writing. Vitality capsules was distributed Nationwide to retail outlets from wholesale distributor.

ACTION:

Consumers should return all purchased product to place of purchase.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

One Source Nutrition, Inc is notifying its distributors and customers by email and is arranging for return of all recalled products. Retailers that have Vitality capsules which is being recalled should return to place of purchase/discard/contact their doctor, etc.

CONTACT:

One Source Nutrition Inc at 501-778-3311 or onesourcelr@gmail.com on Monday thru Friday 10am to 6pm CST.

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm1

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.