Pfizer Recalls Propofol Products After Finding ‘Visible Particulate’ During Annual Inspection

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FILE - The Pfizer logo is displayed at the company's headquarters, Feb. 5, 2021, in New York. (AP Photo/Mark Lennihan, File)

FOR IMMEDIATE RELEASE – NEW YORK, NY., August 22, 2022 Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level 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.

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 (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 NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.

Product

NDC

Lot
Number

Expiration
Date

Presentation

Configuration/
Count

Propofol
Injectable
Emulsion,
100 mL Single
Patient Use
Glass
Fliptop Vial
Vial:
0409-4699-54 Tray:
0409-4699-24
EA7470 01 JUNE 2023 1g/100 mL,
Single
Patient Use
Glass
Fliptop Vial
Tray of 10
Units

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

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