FDA MedWatch – One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol) by Hospira

TOPIC: One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol) by Hospira: Recall – Due To The Potential Presence of Visible Particulates

AUDIENCE: Health Professional, Patient, Risk Manager, Anesthesiology 

ISSUE: Hospira is recalling one lot, EA7470, of Propofol Injectable Emulsion (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial due to visible particulates observed in two vials during annual examination of retention samples.

Risk Statement: 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. Hypersensitivity reactions and transmission of infectious disease can also occur.

To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. 

RECOMMENDATIONS: 

• Hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately.
• Hospitals/Institutions should inform health professionals in your organization of this recall. 
• Health professionals with questions regarding this recall can contact the company. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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