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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77651

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

Open FDA event record

Event summary

Timeline bucket
June 28, 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

parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.

D-0944-2017
Recall number
D-0944-2017
Initiated
June 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
GSK Consumer Healthcare
Quantity
15,708 tubes

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: possibility of the presence of metal in the product.

Code information

G7E101, Exp 04/19

Distribution pattern

Nationwide in the USA