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Recall Observatory FDA recall evidence

Drug product

Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

D-1033-2014

December 12, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 67322
Status
Terminated
Classification
Class II
Quantity
126,425 vials
Official record key
drug-enforcement:D-1033-2014

Official wording

Reason: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

Code information: Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter