Products found to contain undeclared medicines
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| The United States: Epic Products, LLC, issues voluntary nationwide recall of all lots of Euphoric Capsules due to presence of undeclared sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that 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.
This tainted Euphoric product is marketed as a dietary supplement for male sexual enhancement. Euphoric was sold to consumers nationwide in the USA via retail stores. Epic Products, LLC has discontinued sales of these products.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm604729.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Apr 18, 2018
Issued at HKT 15:00
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