Exact FDA event identifier

Event 87944

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

Open FDA event record

Event summary

Timeline bucket: May 13, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Accupac, 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

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

D-0598-2021

Recall number: D-0598-2021
Initiated: May 13, 2021
Classification: Class II
Status: Terminated
Recalling firm: Accupac, Inc.
Quantity: 2,261 cases/24 tubes per case = 54,264 tubes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride

Code information

LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023

Distribution pattern

Naitonwide in the US and Puerto Rico.