Exact FDA event identifier

Event 85127

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

Event summary

Timeline bucket: February 28, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sunstar Guangzhou Ltd.

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

Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01

D-0997-2020

Recall number: D-0997-2020
Initiated: February 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: Sunstar Guangzhou Ltd.
Quantity: 260,000 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviation

Code information

Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15

Distribution pattern

Florida only