Pfizer’s Hospira Recalls Propofol Injectable Emulsion

Hospira, Inc., a Pfizer co., is recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), due to the potential presence of visible particulates, the U.S. Food and Drug Administration said.

The recall involves Propofol Injectable Emulsion100mL Single Patient Use Glass Fliptop Vial with lot EA7470, to the user level. The NDC is Vial: 0409-4699-54, Tray: 0409-4699-24, and expiration date is June 1, 2023.

The affected product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion is a terminally sterilized or TS product. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.

The agency noted that visible particulates were observed in two vials during annual examination of retention samples.

Patients receiving the impacted product may experience potential adverse events, such as blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. It can also result in hypersensitivity reactions and transmission of infectious disease.

However, Pfizer has not received reports of any adverse events associated with the recalled lot to date.

Wholesalers or hospitals with an existing inventory of the lot are urged to discontinue use, stop distribution and quarantine immediately.

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