Hospira, Inc. recalls Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials
Recalled June 20, 2012 · FDA recall D-1382-2012 · Hospira
Hazard
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel · FDA Class II
Units
a) 36,125 vials; b) 31,280 vials
Sold at
Nationwide.
Description
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Product
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (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 →