Hospira Inc. recalls Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4
Recalled October 3, 2012 · FDA recall D-1685-2012 · Hospira
Hazard
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. · FDA Class II
Units
148,630 vials
Sold at
Nationwide
Description
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Product
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Manufacturer(s)
Hospira Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →