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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68481

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

Open FDA event record

Event summary

Timeline bucket
May 05, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Axcentria Pharmaceuticals, LLC

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

Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA

D-1434-2014
Recall number
D-1434-2014
Initiated
May 05, 2014
Classification
Class II
Status
Terminated
Quantity
20,369 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

Code information

G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015

Distribution pattern

Nationwide