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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65731

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

Open FDA event record

Event summary

Timeline bucket
June 27, 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

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

Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.

D-813-2013
Recall number
D-813-2013
Initiated
June 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
268,700 vials

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

Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.

Code information

Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01

Distribution pattern

Nationwide and Guam