Health Supplement company Bodee LLC announced that it is conducting a nationwide voluntary recall of Zencore Plus. Zencore Plus was advertised as a male enhancement product.
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Plus samples found the product contains benzamidenafil.
Benzamidenafil is likely to have the same pharmacological properties as sildenafil, tadalafil and vardenafil, which are the active ingredients of three FDA approved drugs for Erectile Dysfunction (ED).
The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates.
The probability of this occurrence is unknown; therefore, it may cause a public health risk when used as a dietary supplement. Dietary supplements are typically sold with less oversight by the FDA than drugs, and items labeled as a “supplement” can’t promise to cure any disease or condition.
Zencore Plus is sold in health food stores and by mail order on internet nationwide. It is sold as a 2-capsule blister pack or as a 10-capsule blister pack in a retail box. The capsules were supplied by Hi-Tech Pharmaceuticals, Inc., Norcross, GA.