04.23.18
Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in Euphoric renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Consumers who take this product for ED could have underlying cardiovascular disease, FDA cautioned. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse.
To date, Epic Products, LLC has not received any reports of adverse events related to this recall.
Consumers who take this product for ED could have underlying cardiovascular disease, FDA cautioned. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse.
To date, Epic Products, LLC has not received any reports of adverse events related to this recall.
