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Imperia Elita Vitaccino Coffee dietary supplement - recalled due to undeclared Sibutramine and Fluoxetine, USA

2 years ago

United States

Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Vitaccino Coffee weight loss and anxiety dietary supplement
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 11, 2021
Recall details: Glendale, California, Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino 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 Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.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 Elita Vitaccino 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.

Risk Statement: 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. 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 Elita Vitaccino 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 Online. Regular Mail or Fax: Download form 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.

Check the full recall details on fda.gov

Source: FDA

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The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
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- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
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Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

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