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Copyright © 2017 Natural Medicines (www.naturalmedicines.com)
July 2013

Volcano Company Recalls Two Male Sexual Enhancement Products

The U.S. Food and Drug Administration (FDA) recently reported that the Volcano Company has issued a voluntary recall of two of its sexual enhancement products.

These products are Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules.

FDA analysis revealed that Volcano Male Enhancement Liquid was found to contain the undeclared ingredients desmethyl carbodenafil, dimethylsildenafil, and dapoextine, while Volcano Male Enhancement Capsules contained undeclared desmethyl carbodenafil and dapoxetine.

Desmethyl carbodenafil and dimethylsildenafil belong to a class of drugs that is used to treat male erectile dysfunction and are unapproved new drugs. These drugs may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous, life-threatening levels. Men who have diabetes, heart disease, high blood pressure, or high cholesterol often take nitrates.

Dapoxetine is an active ingredient that has not been FDA approved. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which are often used to treat depression. Antidepressants may increase the risk of suicidal thinking and behavior in children and young adults. Consuming these products may pose a life-threatening health risk.

Volcano Male Enhancement Liquid is sold in a two-ounce bottle, 609613859960, LOT 301, and was distributed between January 1, 2013 and July 2013.

Volcano Male Enhancement Capsules are packaged in a round, black or white container with a pop top, UPC 609613859977, LOT 7455, and were distributed between January 1, 2013 and July 2013.

Both products were distributed worldwide through the internet and may be identified by the Volcano Male Enhancement logo on the front of the packages.

Volcano Company has notified distributors and customers via phone and email. It urges consumers in possession of these products to stop using them and return them to the place of purchase or directly to Volcano Company P.O. Box 90277, Long Beach CA, 90809, with an order number or proof or purchase. Questions can be directed to Volcano Company by phone at (562) 363-5362, Monday thru Friday, from 10am to 3pm, Pacific Standard Time.

Any side effects or problems related to using this drug product should be directed to a doctor or other healthcare provider. They may also be reported to the FDA's MedWatch Adverse Event Reporting program.

For more information about erectile dysfunction, please visit Natural Standard's Medical Conditions Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. U.S. Food and Drug Administration. www.fda.gov

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