Volcano Male Enhancement Recall [US]

US/Silver Spring: Volcano Company recalls some Volcano Male Enhancement Liquids, Capsules, marketed as Dietary Supplements, due to undeclared drug hazards. FDA: http://ht.ly/n9Nug

Direct link: http://www.fda.gov/Safety/Recalls/ucm361709.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drugs are subject to this recall:

• Volcano Male Enhancement Liquids are packaged in two (2) ounce bottles; UPC: 609613859960; lot: 301; distributed from January 1, 2013 to July 2013; and
• Volcano Male Enhancement Capsules are packaged in a black or white round plastic pop top container with one (1) capsule inside; UPC: 609613859977; lot: 7455; distributed from January 1, 2013 to July 2013.

Both products are marketed as Dietary Supplements for male sexual enhancement to increase desire and sexual performance.

According to the FDA, test results have shown the Volcano Male Enhancement Liquids contain the undeclared drugs, Desmethyl Carbodenafil, Dimethylsildenafil and Dapoxetine. FDA test results also revealed the company’s Volcano Capsules have been found to contain the undeclared drugs, Desmethyl Carbodenafil and Dapoxetine. Desmethyl Carbodenafil and Dimethylsilsildenafil are Phosphodiesterase (PDE) 5 inhibitors, a class of drugs used to treat male erectile dysfunction. This means the recalled products are unapproved new drugs. Dapoxetine is an active ingredient not approved by the US Food and Drug Administration.

The FDA says Desmthyl Carbodenafil and Dimethylsidenafil may pose a safety hazard 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.

Chemically, Dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression. 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 that could be life threatening.

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Recalls Direct RIN: 2013-2290
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