Hospira recalls lot of Propofol Injectable Emulsion

PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100ml Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].

Pfizer’s Hospira is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100ml 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 statement released by Pfizer, patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects, including blockage of blood vessels (with potential to decrease blood flow to the brain), heart attack, pulmonary embolus and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.

Hospira has, to date, not received reports of any adverse events associated with this issue.

Propofol is an intravenous general anaesthetic and sedation drug for use in the induction and maintenance of anaesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilised (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.

The affected product was distributed nationwide to wholesalers, hospitals and Department of Defense in the US between 10 June 2020 and 26 June 2020. The full details are listed below:

Hospira, stated that it “places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” adding that it has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers or hospitals with an existing inventory of the lot 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 organisation of this recall. For additional assistance contact Sedgwick Inc. at   1-800-805-3093 between the hours of 8am to 5pm ET, Monday through Friday.