FDA Recall D-0628-2021
DASH XCLUSIVE · Glendale, CA
Class II Ongoing 1829 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Recall record
- Recall number
D-0628-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2021-05-11
- Classified by FDA Center
- 2021-06-11
- FDA published
- 2021-06-23
- Recalling firm
- DASH XCLUSIVE
- Firm location
- Glendale, CA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.