Propofol Injectable Emulsion Recalled Due to Visible Particulates in Vials

Hospira has voluntarily recalled 1 lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol) due to visible particulates observed in 2 vials during annual examination of retention samples.

Propofol is an intravenous general anesthetic and sedative drug for use in the induction and maintenance of anesthesia or sedation. The recalled lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 1g/100mL single patient use glass fliptop vial; NDC (vial) 0409-4699-54; NDC (tray) 0409-4699-24; Lot # EA7470; Expiration Date June 1, 2023, was distributed nationwide to wholesalers and hospitals in the United States between July 16, 2020 and July 24, 2020.

To date, the Company has not received any adverse event reports related to this recall. Patients receiving the affected product may be at risk of life-threatening adverse events (eg, blockage of blood vessels); hypersensitivity reactions and infectious disease transmission may also be possible.

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

Reference

Hospira issues a voluntary nationwide recall for one lot of propofol injectable emulsion (containing benzyl alcohol), due to the potential presence of visible particulates. News release. Hospira, Inc. Accessed August 23, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-containing-benzyl