Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported June 23, 2021
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Dash Xclusive recalled Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technolog… - a moderate-severity action.
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technolog… was recalled by Dash Xclusive in June 23, 2021. Reason: Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sib…. Check the official notice for the remedy. Verify recall #D-0628-2021 with the FDA Drug before acting.
The recall
Dash Xclusive issued this moderate-severity FDA Drug recall-Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sib….
- Moderate
- severity level
- Class II
- classification
- June 23, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0628-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0628-2021) was formally reported on June 23, 2021, with the manufacturer initiating the action on May 11, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Dash Xclusive is listed as the recalling firm, operating out of Glendale, CA. Federal records list the affected scope as 25 pieces (boxes containing 15 sachets).
The documented reason for this recall is: Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25 pieces (boxes containing 15 sachets)
Related Recalls
6
5 from same agency
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
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0628-2021 |
| Date reported | June 23, 2021 |
| Date initiated | May 11, 2021 |
| Recalling firm | Dash Xclusive |
| Firm location | Glendale, CA |
| Affected scope | 25 pieces (boxes containing 15 sachets) |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0628-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg. Recalled by Dash Xclusive. Units affected: 25 pieces (boxes containing 15 sachets).
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 23, 2021. Severity: Moderate. Recall number: D-0628-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0628-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 23, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.