Vitility Issues Voluntary Nationwide Recall of Man of Steel Due to Presence of Undeclared Sildenafil
- Company Announcement Date:
- August 04, 2017
- FDA Publish Date:
- February 08, 2018
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionDue to Presence of Undeclared Sildenafil
- Company Name:
- Man of Steel
- Brand Name:
Brand Name(s)Man of Steel
- Product Description:
Product DescriptionMan of Steel 1 and Man of Steel 2
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 firstname.lastname@example.org. 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
Link to Public Notification #1.
Link to Public Notification #2.