Last Updated on October 11, 2024 by The Health Master
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 the annual examination of retained 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, decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis.
Hypersensitivity reactions and transmission of infectious diseases 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.
Propofol Injectable Emulsion, USP 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 flip top vial.
The NDC, Lot Number, Expiration Date, and Configuration Details for Propofol Injectable Emulsion, USP is indicated below.
The product lot was distributed nationwide to wholesalers/ hospitals/Department of Defense in the United States from June 10, 2020, through June 26, 2020.
| Product | NDC | Lot Number | Expiration DatePresentation | Configuration/Count |
|---|---|---|---|---|
| Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial | Vial: 0409-4699-54 Carton: 0409-4699-24 | DX9067 | 01 MAY 2023 | 1 g/100 mL, Single Patient Use Glass Fliptop Vial Case of 10 Units |
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified direct consignees by letter to arrange for the return of any recalled product.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
| Contact Center | Contact Information | Area of Support |
|---|---|---|
| Pfizer Medical Information | 1-800-438-1985, option 3 (8am to 9pm ET Monday through Friday) www.pfizermedinfo.comExternal Link Disclaimer | For medical questions regarding the product |
| Pfizer Drug Safety | 1-800-438-1985, option 1 (24 hours a day; 7 days a week) | To report adverse events and product complaints |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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