Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients

[Posted 11/19/2013]

AUDIENCE: Consumer, Health Professional

ISSUE: Jobbers Wholesale is recalling Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone. FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine, making these products unapproved new drugs. Desmethylcarbondenafil is a posphodiesterase (PDE-5) inhibitor which is a class of drugs used to treat male erectile dysfunction (ED). Dapoxetine is an active ingredient not approved by the FDA. Chemically, dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression.

Desmethylcarbondenafil may pose a threat to consumers because this PDE-5 inhibitor 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 in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening.

BACKGROUND: Rhino 5 Plus, Maxtremezen and Extenzone are labeled and intended to be used as dietary supplements for sexual enhancement. All three products were distributed to selected retail customers in California by Jobbers Wholesale from June 1, 2013 to November 7, 2013.

RECOMMENDATION: Consumers and retailers that have these products which are being recalled should stop consumption or further distribution and return to place of purchase or directly to Jobbers Wholesale, 16101 Garfield Avenue, Paramount, CA 90723. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Consumers with questions regarding this recall can contact Jobbers Wholesale by phone (562-331-0700), from Monday to Friday, 09:00-17:00.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/16/2013 - Press Release - Jobbers Wholesale]