FDA-Drug2012-06-20Class II
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.
Hospira, Inc.
Hazard
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Sold states
Nationwide.
Affected count
a) 36,125 vials; b) 31,280 vials
Manufactured in
600 N Field Dr Bldg J45, Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1382-2012Don't want to check this manually?
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