Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee to the consumer level.
FDA analysis has found the product to contain undeclared sibutramine and fluoxetine, a press release from the FDA stated.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.
Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber.
The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.