FDA MedWatch – Male Enhancement Supplements by Integrity Products

TOPIC: Male Enhancement Supplements by Integrity Products: Recall – Due to Presence of Sildenafil and Tadafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Integrity Products is recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules because FDA analysis founds these products to be tainted with sildenafil and tadalafil. Sildenafil/tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Ram It & To The Moon products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications taken with these products could lower blood pressure to dangerous levels that could be life threatening. 

To date, Integrity Products. has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: The products being recalled are marketed as dietary supplements for male sexual enhancement. 

RECOMMENDATIONS:

• 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.

• Consumers with questions regarding this recall can contact Integrity Products at integrityproductsusa@gmail.com. 

Health professionals and consumers 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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