Exact FDA event identifier

Event 71356

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

Event summary

Timeline bucket: June 03, 2015
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corp

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

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

D-1131-2015

Recall number: D-1131-2015
Initiated: June 03, 2015
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp
Quantity: 145,350 containers

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug; out of specification results for heparin raw material

Code information

Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016

Distribution pattern

Nationwide