Hospira and the FDA notified healthcare professionals of a nationwide recall of three lots of Propofol Injectable Emulsion 1% (1g/100mL), due to visible particles embedded in the glass to the user level.  There may be potential for product to come into contact with the embedded particles, which may become dislodged into the solution. Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.

The affected lots were distributed from September 2011–February 2012. The affected vials have NDC 0409-4699-24 with the following lot numbers and expiration dates:

  • 07-893-DJ (Expiration date 7/1/13)
  • 10-123-DJ (Expiration date 10/1/13)
  • 10-125-DJ (Expiration date 10/1/13)

Propofol is indicated for the induction or maintenance of anesthesia in surgical patients or to initiate sleep in intensive care units.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315746.htm.