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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95219

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

Open FDA event record

Event summary

Timeline bucket
August 20, 2024
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Elevate Oral Care

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

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

D-0658-2024
Recall number
D-0658-2024
Initiated
August 20, 2024
Classification
Class III
Status
Terminated
Recalling firm
Elevate Oral Care
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
LABELING: LABEL MIX-UP

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

LABELING: LABEL MIX-UP.

Code information

Lot #G073DC, Exp 3/31/2026

Distribution pattern

120 direct customers, Nationwide US. No foreign, DOD/VA.