The FDA announced a nationwide recall of seven lots of Propofol Injectable Emulsion 1% (Hospira), due to visible metal particles embedded in the glass to the user level. Upon further analysis, free-floating metal particulates were also identified.
Propofal is indicated for the induction and maintenance of monitored anesthesia care (MAC) sedation, combined sedation and regional anesthesia, ICU sedation of intubated, mechanically ventilated adult patients, induction of general anesthesia in patients ≥3 years of age, and maintenance of general anesthesia in patients ≥2 months of age.
Injected particulate matter could result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate, as well as occlusion of capillaries and granulomatous formation in the lungs. Embedded stainless steel could put patient at risk from MRI as particulate, if in the lung, could potentially dislodge and be pulled through tissue.
The affected lot numbers for 200mg/20mL (10mg/mL) vials are 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, and 29-630-DJ. All lots have the expiration date of May 1, 2015.
For more information visit FDA.gov.