Imperia Elita Vitaccino Coffee — Class II drug recall D-0628-2021
Ongoing recall by DASH XCLUSIVE, reported 2021-06-23, distributed nationwide. Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibu
| Recall number | D-0628-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DASH XCLUSIVE, Glendale, CA, United States |
| Recall initiated | 2021-05-11 |
| Classified | 2021-06-11 |
| Reported by FDA | 2021-06-23 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved 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
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0628-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.