Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients

[Posted 07/22/2013]

AUDIENCE: Consumer

ISSUE: Volcano Company is recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules to the consumer level. 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. 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 which could be life threatening.

BACKGROUND: 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.

Volcano Male Enhancement Capsules are 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.

RECOMMENDATION: Consumers/distributors/retailers that have Volcano Male Enhancement Liquid and/or Volcano Male Enhancement Capsules which is being recalled should stop using and return to place of purchase or directly to Volcano Company P.O. Box 90277, Long Beach CA, 90809.

[07/18/2013 - Press Release - Volcano Company]