Dash
Xclusive Issues Voluntary Nationwide RECALL of Imperia Elita Vitaccino Coffee
Glendale,
California, Dash Xclusive is voluntarily recalling all lots of Imperia
ElitaVitaccino Coffee to the consumer level. FDA analysis has 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withdrawn from the market because of safety issues, including stroke, heart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 ElitaVitaccino 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.
Company
Announcement Date:
May
11, 2021
FDA
Publish Date:
May
11, 2021
Product
Type:
Dietary
Supplements
Reason
for Announcement:
Undeclared
Sibutramine and Fluoxetine
Company
Name:
Dash
Xclusive
Brand
Name:
Imperia
Elita
Product
Description:
Vitaccino
Coffee weight loss and anxiety dietary supplement
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.
The product is marketed as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen sachets. The affected Imperia ElitaVitaccino coffee lots include all lots. Product was distributed Nationwide in the USA via internet and by ebay at www.ebay.com.
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.
Dash
Xclusive is notifying its customers by e-messages on the eBay platform and is
arranging for return of all recalled products. Consumers that have Imperia
ElitaVitaccino Coffee which is being recalled should stop using/return to Dash
Xclusive, 610 S. Verdugo Road, Apt 31, Glendale, California 91205.
Consumers
with questions regarding this recall can contact Dash Xclusive by e-mail
at dashxclusive11@gmail.com on Mondays
to Thursdays from 11am to 4pm Pacific Time zone. 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.
Adverse
reactions or quality problems experienced with the use of this product may be
reported to the FDA's MedWatch Adverse Event Reporting program either online by
regular mail or by fax.
Complete
and submit the report OnlineExternal Link Disclaimer
Regular
Mail or Fax: Download
formExternal Link Disclaimer or call 1-
800-332-1088 to request a reporting form, then complete and return to the
address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This
recall is being conducted with the knowledge of the U.S. Food and Drug
Administration.
Company Contact Information
Consumers:
Dash
Xclusive