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Products found to contain undeclared medicines

 
The United States: Happy Together, Inc. issues voluntary nationwide recall of product due to presence of undeclared sildenafil and tadalafil: Rhino 5k capsules
 
The US Food and Drug Administration (FDA) announces that Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. To date, Happy Together Inc. has not received any reports of adverse events related to this recall.

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 30 count box. Rhino 5k was distributed to consumers nationwide via the internet.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm629353.htm

In Hong Kong, the above product is not a registered pharmaceutical product.

Ends/Wednesday, Jan 9, 2019
Issued at HKT 15:00
 
 
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