Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Hospira, a Pfizer company, announced on July 13, 2022 that the company is issuing a voluntary recall of 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.

According to a Pfizer, patients receiving the impacted product are at risk for 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 used for the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.

The product lot was distributed nationwide in the United States from June 10, 2020 through June 26, 2020. Hospira has not received any reports of adverse events associated with this issue for this lot to date.

Source: Pfizer