Seven lots of Propofol Injectable Emulsion, USP, have been recalled to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during an inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.
In general, injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue.
The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe