Recall -- Firm Press Release
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Jobbers Wholesale Issues Voluntary Recall of Rhino 5 Plus, Maxtremezen and Extenzone Marketed as a Dietary Supplement Due to the Presence of Undeclared Drug Ingredients
FOR IMMEDIATE RELEASE - November 16, 2013 - Paramount, CA, Jobbers Wholesale is voluntarily recalling Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone to the consumer level. FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine. Desmethylcarbondenafil is a phosphodiesterase PDE-5 inhibitor 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).
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. 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 in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening. Jobbers Wholesale has not received any reports of adverse events related to this recall.
These 3 products are labeled and intended to be used as dietary supplements for sexual enhancement. The products are packaged in 1 capsule blister packs. All three products were distributed to selected retail customers in California by Jobbers Wholesale from June 1, 2013 to November 7, 2013.
Jobbers Wholesale is notifying its retailers and customers by telephone and recall letter and is arranging for return of all recalled products. 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 are requested to have order number or proof of purchase.
Consumers with questions regarding this recall can contact Jobbers Wholesale by phone (562-331-0700), from Monday to Friday, 09:00-17:00. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch-Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.