FDA MedWatch – Imperia Elita Vitaccino Coffee by Dash Xclusive: Recall

TOPIC: Imperia Elita Vitaccino Coffee by Dash Xclusive: Recall – Due to Presence of Undeclared Sibutramine and Fluoxetine

AUDIENCE: Consumer, Health Professional

ISSUE: Dash Xclusive is recalling all lots of Imperia Elita Vitaccino Coffee. FDA analysis has 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.

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: The product is marketed  as a dietary supplement for weight loss.

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.

• Consumers that have the product are advised to stop using/return to Dash Xclusive.

Consumers and health professionals 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.