Hospira Propofol Recall

IPSIS Patient Safety Alert 08/23/2022: Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

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 voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level 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.

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.

RECOMMENDATIONS: Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer. Full contact information is available in the full recall statement.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• 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 008/23/2022

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