Public Alert No. 026/2021 – Alert On Recall Of Imperia Elita Vitaccino Coffee By Dash Xclusive Due To The Presence Of Undeclared Sibutramine And Fluoxetine
July 30, 2021,
The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA that Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee. This was due to FDA’s result of analysis which has shown the product contains 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Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.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 these drugs in the recalled product renders it an unapproved drug for which safety and efficacy has not been established.
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 Elita Vitaccino coffee lots include all lots.
NAFDAC implores importers, distributors, retailers and consumers to stop the importation, distribution, sale and use of Imperia Elita Vitaccino Coffee.
Members of the public in possession of the recalled coffee product are implored to discontinue sale or use and handover stock to the nearest NAFDAC office.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via email@example.com or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng