Exact FDA event identifier

Event 68764

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

Event summary

Timeline bucket: July 10, 2014
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Hospira 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

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

D-0392-2015

Recall number: D-0392-2015
Initiated: July 10, 2014
Classification: Class I
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 142,644 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

Code information

Lot # 35-118- JT, Exp. 11/15

Distribution pattern

Nationwide