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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76662

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

Open FDA event record

Event summary

Timeline bucket
March 06, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GSK Consumer Healthcare

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

Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2

D-0624-2017
Recall number
D-0624-2017
Initiated
March 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
GSK Consumer Healthcare
Quantity
56,840 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent

Code information

A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018

Distribution pattern

Nationwide