FDA-Drug2013-08-21Class II

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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

Hospira Inc.
Hazard

Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

Sold states
Nationwide
Affected count
94,110 vials
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-887-2013

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