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Recall Observatory FDA recall evidence

Drug product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

D-0381-2015

December 23, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 70179
Status
Terminated
Classification
Class II
Quantity
126,075 vials
Official record key
drug-enforcement:D-0381-2015

Official wording

Reason: Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Code information: Lot 35-844-DJ, Exp 11/01/2015

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter

Field note

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