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Recall Observatory FDA recall evidence

Drug product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

D-297-2013

April 08, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 64990
Status
Terminated
Classification
Class II
Quantity
245,250 vials
Official record key
drug-enforcement:D-297-2013

Official wording

Reason: Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

Code information: Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter