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Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples.
Risk Statement: Patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects including but not limited to: 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, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot.
Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation.
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