Imperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients
Imperia Elita Vitaccino Coffee sachets are being recalled because they were marketed without FDA approval and contain pharmaceutical ingredients Sibutramine and Fluoxetine. All lots distributed nationwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving unapproved pharmaceutical ingredients (Sibutramine and Fluoxetine) present in a product marketed without required drug approval. The presence of unapproved active pharmaceuticals in an improperly marketed product presents significant health risk due to lack of safety oversight, dosing controls, and medical supervision, meeting Class II criteria for severity.
Plain-English summary
Imperia Elita Vitaccino Coffee, sold in 10-gram sachets (15 sachets per box), is being recalled nationwide. The product was manufactured by Global Beauty Technologies for Imperia-Elita Ltd. & Co, KG in Germany and distributed by DASH XCLUSIVE.
FDA analysis determined that the product was marketed without an approved NDA (New Drug Application) or ANDA (Abbreviated New Drug Application). The analysis found the presence of two pharmaceutical ingredients: Sibutramine and Fluoxetine.
All lots of this product are subject to recall. Consumers should not use this product and should contact the recalling firm or their healthcare provider with questions.
The recalled product
- Product
- Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
- Manufacturer
- DASH XCLUSIVE
- Category
- Drug — Unapproved Drug Product
- Hazard
- unapproved-drug-ingredients
- sibutramine
- fluoxetine
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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