Products found to contain undeclared medicines
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| The United States: TF Supplements issues voluntary nationwide recall of dietary supplements named RHINO 7 with undeclared active pharmaceutical ingredients desmethyl carbondenafil and dapoxetine |
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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 the retail website http://www.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 TF Supplements.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm464440.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, September 29, 2015
Issued at HKT 15:00
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