United States
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. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020. To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.
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.
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.
Product: Configuration/Count Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial
NDC: Vial: 0409-4699-54 Tray: 0409-4699-24
Lot Number: EA7470
Expiration Date: 01 JUNE 2023
Presentation: 1g/100 mL, Single Patient Use Glass Fliptop Vial
Configuration/Count: 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.
Company name: Hospira, Inc., a Pfizer Company
Brand name: Hospira
Product recalled: Propofol Injection Emulsion, USP
Reason of the recall: Potential presence of visible particulate
FDA Recall date: August 22, 2022
Source:
www.fda.gov
