CASPER, Wyo. — An “all-natural libido” product marketed for both men and women is being recalled because it may be contaminated with an erectile dysfunction drug which could lower blood pressure in some individuals “to dangerous levels which can be life-threatening.”
All lots of the “Up2” dietary supplement is being voluntarily recalled by Med Man Distribution after laboratory analysis from the United States Food & Drug Administration revealed it may contain sildenafil.
“Sildenafil is an FDA-approved prescription drug for erectile dysfunction,” an announcement from the company posted by the FDA states. “The presence of sildenafil in Up2 products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.”
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Sildenafil can interact with nitrates such as nitroglycerin, which can be found in some prescription drugs, the announcement adds.
That may act to lower blood pressure “to dangerous levels which can be life threatening.”
“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected,” the release adds. “To date, Med Man has not received any reports of adverse events related to this recall.”
The product has been distributed nationwide.
“Med Man is notifying its distributors and their customers by written email and is arranging for destruction of all recalled products,” the announcement adds.
Consumers are asked to stop using the supplement and return it to retailers for refunds.
“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,” the release adds.
Reports can be made in the following ways: