Class I Recall for Anesthetic, Sedation Drug

Hospira Inc, a Pfizer company, is voluntarily recalling one lot of propofol injectable emulsion due to visible particulates observed in 2 vials during an annual examination of retention samples. According to the September 21, 2022, US Food and Drug Administration (FDA) Enforcement Report, the recall received a Class I designation—a classification that warns use of the affected product could cause serious adverse health consequences or death.

“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,” Pfizer stated in an August 22, 2022, company announcement. “Hypersensitivity reactions and transmission of infectious disease can also occur.”

The recall affects propofol injectable emulsion (containing benzyl alcohol), 100-mL single-patient use, glass flip-top vials (NDC 0409-4699-54), packaged in a tray of 10 vials (carton NDC 0409-4699-24), from lot EA7470 (Exp. 6/1/23). The product was distributed nationwide to wholesalers/hospitals from July 16, 2020, through July 24, 2020.

Pfizer initiated the recall August 22, 2022. The FDA issued its Class I recall designation on September 19, 2022.

Propofol is an intravenous general anesthetic and sedation drug used in the induction and maintenance of anesthesia or sedation.