FDA MedWatch - Imperia Elita Vitaccino Coffee by Dash Xclusive:

Recall - Due to the Presence of Undeclared Sibutramine and Fluoxetine

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Imperia Elita Vitaccino Coffee by Dash Xclusive: Recall - Due to the Presence of Undeclared Sibutramine and Fluoxetine AUDIENCE: Consumer, Health Professional ISSUE: Dash Xclusive is recalling all lots of Imperia Elita Vitaccino Coffee because FDA analysis found the product to contain undeclared sibutramine and fluoxetine.  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. 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. 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. Dash Xclusive has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND:  Imperia Elita Vitaccino Coffee is marketed as a dietary supplement for weight loss. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.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 boxed warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber.   RECOMMENDATIONS:  On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Consumers that have Imperia Elita Vitaccino Coffee which is being recalled should stop using/return to Dash Xclusive Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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