Health regulator recalls male sexual enhancement supplements as ‘unapproved drugs’

*The Food and Drug Administration announces that Integrity Products, based in St Louis, is recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules, noting its analysis found the affected products to be tainted with sildenafil and Tadalafil

Alexander Davis | ConsumerConnect

The United States (US) Food and Drug Administration (FDA) has announced that Integrity Products, based in St Louis, is recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level.

ConsumerConnect learnt the FDA analysis found the affected 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 and therefor, are subject to recall.

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

The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.

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

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card, 10-count boxes. Ram It & To The Moon were distributed to consumers nationwide via the Internet, according to report.

In regard to what consumers should do, the FDA stated: “We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product.

“Integrity Products is notifying its customers that have the Ram It & To The Moon products to stop use and properly discard the product.”

Consumers with questions regarding this recall can contact Integrity Products at integrityproductsusa@gmail.com, St Louis, Monday – Friday 9 am to 9 pm ET.

The FDA said 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.