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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64719

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

Open FDA event record

Event summary

Timeline bucket
February 25, 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

Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.

D-223-2013
Recall number
D-223-2013
Initiated
February 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
68,020 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: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.

Code information

a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.

Distribution pattern

Nationwide.