July 22, 2013
Volcano Company Recalls Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules, Marketed as a Dietary Supplement
The Missouri Department of Health and Senior Services received information regarding a recall 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 U.S. Food and Drug Administration (FDA).
Volcano Male Enhancement Liquid is marketed as a dietary supplement for male sexual enhancement 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.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm361709.htm?source=govdelivery.