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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87923

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 11, 2021
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DASH XCLUSIVE

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0628-2021
Initiated
May 11, 2021
Classification
Class II
Status
Ongoing
Recalling firm
DASH XCLUSIVE
Quantity
25 pieces (boxes containing 15 sachets)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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