Hospira Propofol Recall

IPSIS Patient Safety Alert 07/14/2022: Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the U.S. Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

ISSUE: Hospira, Inc., a Pfizer company, is recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, due to a visible particulate observed in a single vial during annual examination of retain samples.

RISK STATEMENT: Patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects including but not limited to: 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, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot.

Click here for more information about this alert, including the U.S. Food and Drug Administration's National Drug Code (NDC) and Hospira's lot number, expiration date, and configuration details for this Propofol Injectable Emulsion, USP.

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 should stop use and quarantine immediately.
  
• Hospitals/Institutions should inform healthcare professionals in your organization of this recall.
• Healthcare 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 Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
  

Source: Food and Drug Administration - Accessed 07/14/2022

Help sustain this vital dissemination of patient safety information with your donations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.