Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Product description
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0628-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 11, 2021
- FDA report date
- Jun 23, 2021
- Quantity
- 25 pieces (boxes containing 15 sachets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DASH XCLUSIVE
Original FDA data
Every field from FDA enforcement report D-0628-2021, exactly as published.
Show all FDA fields
- City
- Glendale
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87923
- Address
- 610 S Verdugo Rd Apt 31
- Code information
- All Lots
- Postal code
- 91205-2730
- Report date
- Jun 23, 2021
- Product type
- Drugs
- Recall number
- D-0628-2021
- Classification
- Class II
- Recalling firm
- DASH XCLUSIVE
- Product quantity
- 25 pieces (boxes containing 15 sachets)
- Reason for recall
- Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 11, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jun 11, 2021