FDA-Drug2013-09-18Class II

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

Hospira Inc.
Hazard

Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.

Sold states
Nationwide
Affected count
283,150 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-932-2013

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