April 18, 2018
ISSUE: Overland Park, KS, 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. 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.
BACKGROUND: This tainted Euphoric product is marketed as a dietary supplement for male sexual enhancement and is 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). All lots of Euphoric are included in this recall. Euphoric was sold to consumers nationwide in the USA via retail stores. Epic Products, LLC has discontinued sales of these products.
RECOMMENDATION: Epic Products is notifying its distributors and customers by email and phone calls and is arranging for return of all recalled products. Consumers/Distributors/retailers that have Euphoric which is being recalled should stop use/distribution and return to place of purchase.
Consumers with questions regarding this recall can call 1-800-589-1470 between the hours of 9:00am and 6:00pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[04/16/2018 – Press Release – Epic]