What's the Problem?
This recall was initiated after an FDA analysis found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss, but was withdrawn from the U.S. market due to safety issues including stroke, heart failure and other serious health risks. Fluoxetine is an FDA approved drug used to treat depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. It carries a boxed warning for suicidal thoughts and behaviors and needs to be monitored closely by a prescriber.
"Products containing undeclared sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke," FDA said. "Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels."
Imperia Elita Vitaccino Coffee is marketed as a dietary supplement for weight loss and is packaged in a black rectangular box and contains 15 sachets. The affected products were distributed nationwide via Internet sales.
If you purchased any coffee that is affected by this recall, you should either throw it away or return it to the point of purchase for a refund.
Anyone concerned about a potential adverse reaction to dietary supplements should contact their healthcare provider immediately.
This recall began on May 11, 2021.
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Do I Have an Imperia Elita Vitaccino Coffee Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Imperia Elita Vitaccino Coffee Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or another loved one was harmed by Imperia Elita Vitaccino Coffee, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.