What’s the Problem?
This FDA Recall began on May 11, 2021, and was initiated after routine testing found the Imperia Elita Vitaccino Coffee to contain undeclared sibutramine and fluoxetine.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss, but was recalled due to an increased risk for serious side effects including stroke and heart failure. 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.
Serious side effects of undeclared sibutramine and fluoxetine may include:
- Increased blood pressure and/or pulse rate, especially in patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke
- Suicidal thinking and behavior
- An accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions
- Elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep
- Abnormal bleeding
- Low sodium levels
“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,” FDA said.
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.
Consumers who purchased any recalled coffee should either discard it or return it for a refund.
Anyone concerned about a potential adverse reaction to dietary supplements should contact their healthcare provider immediately.
Do I Have an Imperia Elita Vitaccino Coffee Class Action Lawsuit?
The Class Action 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.