Hospira Inc., which is a Pfizer company, voluntarily initiated a nationwide recall on August 22, 2022, of one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, because they might contain particulates.
Hospira initiated this user-level recall after an annual examination of retention samples which showed the presence of visible particulates in two vials.
Risk Statement
The presence of visible particulates in Propofol Injectable Emulsion (containing benzyl alcohol) may result in local irritation and inflammation upon injection, which could lead to serious adverse events including but not limited to:
- Blockage of blood vessels
- Infection
- Tissue necrosis
- Pulmonary embolus
- Decreased blood flow to the brain
The effects can also cause hypersensitivity reactions as well as infectious disease transmission.
Pfizer has not received any reports of adverse events related to this issue to date.
Propofol is an intravenous (IV) sedative-hypnotic agent used for the induction and maintenance of general anesthesia, as well as for procedural sedation. It is often used in operating rooms and intensive care units to help patients remain unconscious during surgery or mechanical ventilation.
Propofol is available in two formulations: a propofol emulsion and liposomal propofol. Propofol Injectable Emulsion is a terminally sterile (TS) product that contains 10 mg/mL supplied in a Single Patient Use Glass Fliptop Vial for intravenous administration.
This product was supplied to wholesalers/hospitals in the US from July 16, 2020, through July 24, 2020. Here are the details about the product:
Product: 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
Actions to Take
If you have any of the affected lots of Patient Use Glass Fliptop Vials, please discontinue using them immediately.
Wholesalers and hospitals that still have the inventory of the affected lots should stop the use and distribution and quarantine them immediately. If you have distributed this product to any other customers, please notify them of this issue immediately.
Hospira Inc. also urges hospitals/institutions to inform their healthcare providers of this matter.
If you have any questions or need more information, please contact Sedgwick Inc. at 1-800-805-3093 Monday through Friday from 8 a.m. to 5 p.m.
Medical professionals with questions regarding this matter can contact Pfizer using the following methods.
For medical questions on the product:
Contact Pfizer medical information at 1-800-438-1985, option 3 (8 am to 9 pm ET Monday through Friday) or www.pfizermedinfo.com.
To report adverse events and product complaints:
Pfizer Drug Safety 1-800-438-1985, option 1 (24 hours a day; 7 days a week).
Any adverse reactions or quality issues associated with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online by fax at 1-800-FDA-0178.
This recall is conducted with the knowledge of the U.S. Food and Drug Administration.
