Drug 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
D-0628-2021
Product summary
- Firm
- DASH XCLUSIVE
- Event
- Event 87923
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25 pieces (boxes containing 15 sachets)
- Official record key
drug-enforcement:D-0628-2021
Official wording
Reason: Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Code information: All Lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine