Exact FDA event identifier

Event 65400

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

Event summary

Timeline bucket: June 06, 2013
Product types: Drug
Classifications: Class II
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

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

D-608-2013

Recall number: D-608-2013
Initiated: June 06, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 676,872 containers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

Code information

Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02

Distribution pattern

Nationwide and Puerto Rico