Hospira is recalling one lot, EA7470, of Propofol Injectable Emulsion (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial due to visible particulates observed in two vials during annual examination of retention samples.
Risk Statement: Patients receiving the impacted product have a remote probability of experiencing potential adverse events, such as blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.
To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.
BACKGROUND: Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation.
RECOMMENDATIONS:
Hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately.
Hospitals/Institutions should inform health professionals in your organization of this recall.
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