Nuway Distributors is recalling APEXXX tablets due to an illegal ingredient.
Food and Drug Administration (FDA) analysis found APEXXX to contain amounts of sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED). The substance, however, does not appear on the ingredient label, making this a tainted dietary supplement and an unapproved drug.
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. APEXXX is packaged in a single blister pack containing one tablet. The packaging is black with a yellow diamond shaped tablet embossed with the wording APEXXX and UPC 705105963617. All lots are affected by the recall.
Additionally, Nuway is recalling all lots of OPAL tablets, a product from the same vendor as the APEXXX product. OPAL is packaged in a single blister pack containing one tablet, with UPC 794504852400. OPAL can be identified by its black packaging.
The recalled items were sold from 2014 to June 2015 in retail store located in Orlando, Florida. It may have also been distributed online.
Nuway Distributors is notifying its customers by press release and is arranging for a return of all recalled and removed products.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Consumers with questions regarding this recall can contact Nuway Distributors by email at firstname.lastname@example.org and by phone at (407) 722-0061.