Type I Recall of Propofol Injection, 1g/100mL and 500mg/50mL

Hospira Healthcare Corporation is recalling two lots of Propofol Injection, 1g/100mL, lot 79834DJ & 500 mg/50mL, lot 79883DJ, (DIN: 02236887, expiry date: 2012/07/01). The recall was initiated on October 14, 2009 and classified as a TYPE I risk as per Health Canada's recommendation due to the presence in the propofol vials of particulate matter identified as stainless steel. These lots were distributed to hospitals starting in October 2009.

-Infused intravenous stainless steel particulate matter may acutely cause direct mechanical damage on entry to the body (e.g. phlebitis), sub-acute and escalating damage to the body through the Systemic Inflammatory Response Syndrome (SIRS) cascade and/or chronic granuloma formation in the lungs, vascular occlusion, subsequent embolism and may result in death.

"Propofol is an intravenous hypnotic agent for use in the induction and maintenance of general anesthesia or sedation for inpatient and outpatient surgery. Propofol is also indicated for pediatric anesthesia in children 3 years of age or older. It may also be used for sedation during diagnostic procedures and should only be administered to intubated, mechanically ventilated patients in the Intensive Care Unit (ICU) to provide continuous sedation and control of stress responses."

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Published on Oct-30-09