Safety Report: Pfizer Propofol Injection Emulsion, USP - recalled due to Potential presence of visible particulate, USA

United States

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 annual examination of retain samples. The product lot was distributed nationwide to wholesalers/ hospitals/Department of Defense in the United States from June 10, 2020 through June 26, 2020.

The recalled product is:
- Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial, NDC: Vial: 0409-4699-54 Carton: 0409-4699-24, Lot Number: DX9067, Expiration Date Presentation: 01 MAY 2023, Configuration/Count: 1 g/100 mL, Single Patient Use Glass Fliptop Vial Case of 10 Units.

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, 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, 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 fliptop vial.

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. 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: July 13, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-usp-containing