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Recall Observatory FDA recall evidence

Drug product

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

D-1672-2012

August 03, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 62999
Status
Terminated
Classification
Class II
Quantity
56,420 vials
Official record key
drug-enforcement:D-1672-2012

Official wording

Reason: Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

Code information: 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter