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

Summary

Company Announcement Date:: July 13, 2022
FDA Publish Date:: July 13, 2022
Product Type:: Drugs
Reason for Announcement:: Recall Reason Description

Potential presence of visible particulate
Company Name:: Hospira Inc, A Pfizer Company
Brand Name:: Brand Name(s)
Product Description:: Product Description

Propofol Injection Emulsion, USP

Company Announcement

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL 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.

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.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilized (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 NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion, USP is indicated below. The product lot was distributed nationwide to wholesalers/ hospitals/Department of Defense in the United States from June 10, 2020 through June 26, 2020.

Product	NDC	Lot Number	Expiration DatePresentation	Configuration/Count
Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial	Vial: 0409-4699-54 Carton: 0409-4699-24	DX9067	01 MAY 2023	1 g/100 mL, Single Patient Use Glass Fliptop Vial Case of 10 Units

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

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, 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 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 using the below information.

Contact Center	Contact Information	Area of Support
Pfizer Medical Information	1-800-438-1985, option 3 (8am to 9pm ET Monday through Friday) www.pfizermedinfo.com	For medical questions regarding the product
Pfizer Drug Safety	1-800-438-1985, option 1 (24 hours a day; 7 days a week)	To report adverse events and product complaints

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
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.