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Products found to contain undeclared medicines

 
The United States: Nuway Distributors llc issues voluntary [worldwide/nationwide] recall of APEXXX due to presence of undeclared slidenafil
 
Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.

Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. This product marketed as a dietary supplement for male sexual enhancement.

Nuway Distributors llc is also removing all lots of OPAL tablets to the consumer level because this product is sourced from the same vendors as the APEXXX product.

APEXXX and OPAL were sold in a retail store located in Orlando, Florida for further sale in smoke shops, convenience stores and gas stations. These products may also have been further sold online.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm478919.htm

In Hong Kong, the above products are not registered pharmaceutical products. Related news was issued by the US FDA, and was posted on the Drug Office website on 26 October 2015.


Ends/ Thursday, December 24, 2015
Issued at HKT 14:00
 
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