# FDA recall D-0628-2021

> **DASH XCLUSIVE** · Class II · drug recall initiated 2021-05-11.

## 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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0628-2021
- **Recalling firm:** DASH XCLUSIVE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-05-11
- **Report date:** 2021-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glendale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2021

## Citation

> AI Analytics. FDA recall D-0628-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0628-2021. Source: US FDA. Licensed CC0.

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