FDA MedWatch - Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumer

ISSUE: Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil. The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.

BACKGROUND: The product is marketed as a male enhancement supplement and is packaged in individual blister package. The affected product Man of Steel lots include the following expiration dates: 10-17-18. Man of Steel was distributed throughout local convenience stores in Sacramento, California.

RECOMMENDATION: Man of Steel is notifying its distributors and customers by print media and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have Man of Steel which is being recalled should stop using/return to place of purchase/discard/contact their doctor.

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
• 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

Read the MedWatch safety alert at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm569250.htm