Products found to contain undeclared medicines
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| The United States: Premiere Sales Group issues voluntary nationwide recall of all lots of Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules due to undeclared active pharmaceutical ingredients desmethyl carbondenafil and dapoxetine |
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Premiere Sales Group of Santa Clarita, California is voluntarily recalling the following products to the consumer level: RHINO 7 3000 capsules packaged in a bottle containing six (6) capsules UPC: 616453150126 ALL LOT NUMBERS WITHIN EXPIRY and Rhino 7 Platinum 3000 Capsules packaged in a single (1) blister packs hang card count UPC: 700729253748 ALL LOT NUMBERS WITHIN EXPIRY. 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.
Premiere Sales has not received a report of any adverse events associated with these products.
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. Premiere Sales Group has discontinued sales of these products.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm469981.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news has been issued by the US FDA and was posted on the Drug Office website on 10 October 2015.
Ends/ Thursday, October 29, 2015
Issued at HKT 14:30
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