TF Supplements Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical Ingredients
FOR IMMEDIATE RELEASE — September 25, 2015 — Houston, TX — TF Supplements of Houston, TX, is voluntarily recalling the following product to the consumer level: RHINO 7 packaged in a bottle containing six (6) capsules WITH LOT# K824B719-P and in a single (1) count capsule hang card with LOT# SU-5102617*RP at the consumer level. Lot numbers are on the back top right of the (1) count and on the side of the (6) 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).
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 has received no reports of illness associated with these products to date.
These products are marketed as dietary supplements for sexual enhancement and packaged in (6) count bottle and (1) count hanging card and distributed to consumers nationwide via are our retail website tfsupplements.com. TF Supplements has discontinued sales of these products.
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 can return the products to :
6666 Gulf Freeway
Consumers with questions regarding this recall can contact TF Supplements by telephone at 866-620-3586 between (Monday — Friday 9:00am to 5:00pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. Consumers can report adverse reactions or quality control problems to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax as follows:
Complete and submit reporting form online at http://www.fda.gov/MedWatch/report.htm; or
Mail or fax reporting form. Download form at http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1078.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.