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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Dietary Supplements

DASH XCLUSIVE: Imperia Elita Vitaccino Coffee Recalled for Unapproved Pharmaceutical Ingredients

Agency Publication Date: June 11, 2021
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Summary

DASH XCLUSIVE is recalling 25 boxes of Imperia Elita Vitaccino Coffee (10 g sachets) because FDA analysis found the product contains Sibutramine and Fluoxetine, which are not approved for use in this product. Sibutramine was previously an FDA-approved drug for weight loss but was withdrawn from the market in 2010 because it increases the risk of heart attack and stroke. Fluoxetine is a prescription medication used to treat depression and other disorders. These undeclared ingredients were found in all lots of the coffee, which was distributed nationwide in the United States.

Risk

Sibutramine can significantly increase blood pressure and heart rate, posing a major risk to people with a history of heart disease, heart failure, or stroke. Fluoxetine can cause serious side effects including suicidal thoughts, abnormal bleeding, and seizures, and may cause life-threatening reactions when mixed with other common medications.

What You Should Do

  1. Identify if you have the affected product by checking for 'Imperia Elita Vitaccino Coffee' in 10 g sachets (15 sachets per box), manufactured for Imperia-Elita Ltd. & Co. This recall affects all lot numbers.
  2. Stop using the coffee immediately and do not consume any remaining sachets.
  3. Contact your healthcare provider or pharmacist for guidance, especially if you have experienced any unusual symptoms or have a history of heart conditions.
  4. Return any unused product to the place of purchase for a refund and contact DASH XCLUSIVE for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Imperia Elita Vitaccino Coffee (10 g sachets, 15 sachets per box)
Model:
D-0628-2021
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87923
Status: Active
Manufacturer: DASH XCLUSIVE
Manufactured In: United States
Units Affected: 25 pieces (boxes containing 15 sachets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.