Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Vitility Issues Voluntary Nationwide Recall of Man of Steel Due to Presence of Undeclared Sildenafil

For Immediate Release

August 4, 2017

Contact

Consumers

vitility@yahoo.com
877-757-8335
 

Announcement

Vitility is voluntarily recalling Man of Steel to the consumer level. FDA analysis found these products to be tainted with sildenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Man of Steel products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

Risk Statement: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that taken with these products could lower blood pressure to dangerous levels that could be life threatening. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. Man of Steel has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplements for male sexual enhancement and is packaged in 1-count individual packages. The affected Man of Steel product does not contain a lot number but is labeled with expiration date of 10-17-18. The product was distributed throughout local convenience stores in Sacramento, California.

Vitility is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have the Man of Steel products which are being recalled should stop use/distribution and return to place of purchase.

Consumers with questions regarding this recall can contact Vitility 877-757-8335, Monday-Friday 8am-7pm Pacific Time Zone or e-mail vitility@yahoo.com. 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.

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.

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

Link to Public Notification #1.

Link to Public Notification #2.

###

Page Last Updated: 08/21/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English