Exact FDA event identifier

Event 68449

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

Event summary

Timeline bucket: June 06, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Estee Lauder Inc

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France

D-1452-2014

Recall number: D-1452-2014
Initiated: June 06, 2014
Classification: Class III
Status: Terminated
Recalling firm: Estee Lauder Inc
Quantity: 3,791 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Stability Data Does Not Support Expiry

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Data Does Not Support Expiry

Code information

All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000

Distribution pattern

Nationwide