Nuway Distributors is voluntarily recalling all lots of APEXXX tablets, because they contain sildenafil, a PDE-5 inhibitor, making this supplement an unapproved new drug. Sildenafil, an FDA-approved drug for erectile dysfunction, may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. The product may also cause headaches and flushing.
This product is marketed as a dietary supplement for male sexual enhancement. It is packaged in a single blister pack containing 1 tablet. The UPC number is 705105963617. All lots of APEXXX sold in 2014 to June 2015 are included in this recall. APEXXX can be identified by black packaging. The yellow diamond shaped tablet is embossed with “APEXXX”. It was sold in retail stores in Orlando, Florida for further sale in smoke shops, convenience stores, and gas stations. It may have been sold online.
In addition, Nuway Distributors is removing all lots of OPAL tablets because this product is sourced from the same vendors as the APEXXX product out of an abundance of caution. This product is packaged in a single blister pack containing 1 tablet, with UPC number 794504852400. It is a black diamond-shaped tablet, also sold in a retail store in Orlando, Florida. It may have been sold online, in smoke shops, convenience stores, and gas stations.
If you purchased either of these products, do not use them and return them to the place of purchase for a refund. You can report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.