The Food and Drug Administration (FDA) has uncovered hidden pharmaceutical drugs in two different dietary supplements manufactured, marketed and/or distributed in the U.S. for male sexual enhancement, and has requested the companies issue recalls of the tainted products because they pose a risk to public health.
AMA Wholesale Inc., is recalling Rhino 69 Extreme 50000 capsules because they were found to contain tadalafil, the active ingredient in the erectile dysfunction (ED) drug Cialis. Epic Products LLC is recalling all lots of Euphoric capsules, because testing revealed the products contained undeclared tadalafil as well as sildenafil, the active ingredient in the erectile dysfunction drug Viagra.
The presence of these drugs in dietary supplements renders them unapproved medications for which the safety and efficacy has not been established, and thus subject to recall. Furthermore, consumers who take these supplements for sexual enhancement could have underlying cardiovascular disease. People with diabetes, hypertension, high cholesterol, or heart disease often take nitrates. Use of nitrates along with tadalafil or sildenafil could lead to fatal cardiovascular problems. To date, neither company has received reports of adverse events related to the hidden drugs in their supplements.
Rhino 69 Extreme 50000 was sold in single capsule, blister packs with an expiration date of 12/2022, and UPC Code: 71822071128. The product was distributed nationwide through internet sales to customers. Euphoric capsules were packaged in 1-count blister cards (UPC 6-9685928646-9), 3-count bottles (UPC 6-9685928646-6), and 12-count bottles (UPC 6-9685928648-3) directly to consumers through retail stores nationwide.
Any adverse events related to these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA recall notice