Exact FDA event identifier

Event 62461

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

Event summary

Timeline bucket: September 06, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Church & Dwight 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

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.

D-061-2013

Recall number: D-061-2013
Initiated: September 06, 2012
Classification: Class II
Status: Terminated
Recalling firm: Church & Dwight Inc
Quantity: 42,768 pumps

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.

Code information

Lot #: BI1041, Exp 02/13

Distribution pattern

Nationwide