TF Supplements of Houston, TX, is voluntarily recalling RHINO 7 3000 capsules packaged in a bottle containing six capsules and Rhino 7 Platinum 3000 Capsules packaged in a single blister packs hang card count.
Rhino 7 Platinum 3000 bottle containing six capsules UPC: 616453150126 ALL LOT NUMBERS WITHIN EXPIRY
Rhino 7 Platinum 3000 single blister packs UPC: 700729253748 ALL LOT NUMBERS WITHIN EXPIRY.
Lot numbers are on the back top right of the count and on the side of the six count bottle.
FDA analysis found these products to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil 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).
FDA explained that desmethyl carbondenafil 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.
TF SUpplements discontinued the sales
FDA said that TF Supplements had received a report of one adverse event associated with these products to date.
These products are marketed as dietary supplements for sexual enhancement and packaged in count bottle and count hanging card and distributed to consumers nationwide via our retail website tfsupplements.com. FDA noted that TF Supplements has discontinued sales of these products.