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Volcano recalls dietary supplement containing unapproved new drug

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Staff writer |
VolcanoThe U.S. Food and Drug Administration (FDA) reporeted that Volcano Company is voluntarily recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules.


FDA test results revealed the Volcano Male Enhancement Liquid has been found to contain undeclared Desmethyl Carbodenafil, Dimethylsildenafil, and Dapoxetine. FDA test results revealed Volcano Capsules have been found to contain undeclared Desmethyl Carbodenafil and Dapoxetine.

Desmethyl Carbodenafil and Dimethylsilsildenafil are Phosphodiesterase (PDE) 5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the FDA.

Desmthyl Carbodenafil and Dimethylsidenafil may pose a threat to consumers because these PDE 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels that can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine has not been approved by the FDA and therefore its safety or efficacy has not been established.

Studies have shown that antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening. Volcano Company has not received any reports of adverse events related to this recall.

Volcano Male Enhancement Liquid is marketed as a dietary supplement for male sexual enhancement to increase desire and sexual performance and is packaged in a 2 oz. Bottle, UPC 609613859960, LOT 301, distributed from January 1, 2013 to July 2013 and Volcano Male Enhancement Capsules is packaged in a black or white round plastic pop top container with 1 capsule inside, UPC 609613859977, LOT 7455, distributed from January 1, 2013 to July 2013.

The products were distributed through the internet. The product can be identified by the Volcano Male Enhancement logo displayed on the front side of product package. Volcano Male Enhancement was distributed Worldwide/Nationwide.

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