Exact FDA event identifier

Event 61838

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

Event summary

Timeline bucket: May 09, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Grandpa Brands Co

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

Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

D-1425-2012

Recall number: D-1425-2012
Initiated: May 09, 2012
Classification: Class II
Status: Terminated
Recalling firm: Grandpa Brands Co
Quantity: Lot #C2501: 18150 pieces of gum (1 per package); Lot #B2111: 18129 pieces of gum (1 per package)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent; benzocaine

Code information

Lot #s C2501 & B2111

Distribution pattern

Nationwide