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Recall Observatory FDA recall evidence

Drug product

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

February 25, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 64719
Status
Terminated
Classification
Class II
Quantity
68,020 vials
Official record key
drug-enforcement:D-223-2013

Official wording

Reason: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter