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.
Reason for recall: Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Recall initiated: 20120411
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated