UPDATED: Three Distributors Recall Supplement Due to Illegal Ingredients
A discount supplement manufacturer is voluntarily recalling a product due to the discovery of an unapproved ingredient.
TF Supplements announced the recall this week after Food and Drug Administration (FDA) testing revealed the presence of undeclared desmethyl carbondenafil and dapoxetine in Rhino 7 Platinum 3000, a male sexual enhancement pill.
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 that does not have FDA approval.
Rhino 7 is packaged in a single count card or a six capsule bottle. The recalled single count cards bear the lot number SU-5102617*RP while the six capsule bottle features lot number K824B719-P.
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 levels that can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
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.
TF Supplements has received no reports of illness associated with these products to date.
Rhino 7 was distributed nationwide through TF Supplements' website. The sale of this product has been discontinued.
TF Supplements is notifying its customers via e-mail of this voluntary recall. Consumers that purchased these products from TF Supplements should stop using them immediately and return them to the company at: TF Supplements, 6666 Gulf Freeway, Houston,TX 77087.
Consumers with questions should contact the company at (866) 620-3586.
Update: TF Supplements has expanded the recall to include all lots within the expiry of Rhino 7 Platinum 3000. The initial announcement included only two lots of the product. The supplement packaged as a single pill bears UPC 700729253748, while the six capsule bottle bears UPC 616453150126. According to the FDA update, the company has now received one report of an adverse event associated with the product, though no details are available.
Premiere Sales Group is also issuing a recall for Rhino 7 Platinum 3000 due to the same concerns. The recall applies to all capsules within expiry. Premier Sales has received no reports of incident in connection with the supplement.
Additionally, National Video Supply is voluntarily recalling the same product, for all capsules within expiry. The firm has received no reports of incident or illness. Consumers that purchased these products from National Video Supply should stop using them immediately and can return the products to: 21100 Centre Pointe Park Way, Santa Clarita, CA 91350.