Dash Xclusive recalled all lots of weight loss and anxiety dietary supplement Imperia Elita Vitaccino Coffee for potentially containing undeclared sibutramine and fluoxetine, the U.S. Food and Drug Administration or FDA said in a statement.
The company said the presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug or supplement for which safety and efficacy has not been established.
Dash Xclusive noted that it is yet to receive any reports of adverse events involving the recalled product.
The product is marketed as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen 10g sachets. They were distributed across the U.S. via internet and by ebay at www.ebay.com.
The company urged consumers that have Imperia Elita Vitaccino Coffee which is being recalled to stop consuming it and return them to Glendale, California-based Dash Xclusive. It is also notifying its customers by e-messages on the eBay platform.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.
Meanwhile, Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug has a warning label for suicidal thoughts and behaviours.
Vitaccino Imperia Elita is a 100 percent natural coffee that combines two of the most successful slimming products – Baian Lishou slimming coffee and Vitaccino Imperia Elita slimming coffee. The Vitaccino Imperia Elita slimming coffee is made of African-Ethiopian black coffee Moyojava, soluble low-fat milk and natural extracts.
In December 2020, the FDA issued a warning to consumers to avoid certain male enhancement and weight loss products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.
All 26 of the products the FDA purchased on Amazon and 20 of 25 products, or 80 percent, purchased on eBay contained undeclared active pharmaceutical ingredients, including sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and/or fluoxetine.
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