summary

Company Announcement Date:
FDA Release Date:
Product Type:
drugs

Reason for announcement:

Description of the reason for the recall

Possible presence of visible particles

Name of the company:
Hospira, Inc., a Pfizer company
Brand Name:
Product description:

Product description

Propofol Injection Emulsion, USP


corporate announcement

FOR IMMEDIATE RELEASE – NEW YORK, NY., August 22, 2022 Hospira, Inc., a Pfizer Company, is voluntarily recalling a lot of Propofol Injectable Emulsion (with Benzyl Alcohol), 100 mL Single-Use Glass Vial; Lot EA7470, at user level due to visible particulates observed in two vials during annual hold sample investigation.

Risk Warning: Patients receiving the affected product have a low probability of experiencing potential adverse events such as B. Blockage of blood vessels, including reduced blood flow to the brain, heart attack, pulmonary embolism and tissue necrosis. Hypersensitivity reactions and the transmission of infectious diseases can also occur.

Pfizer has not received any reports of adverse events related to this issue for this lot.

Propofol is an intravenous general anesthetic and sedative for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion is a terminally sterilized (TS) product. It is a sterile, non-pyrogenic, 10 mg/ml propofol emulsion suitable for intravenous administration and is supplied in a single-use flip-top glass vial.

The NDC, lot number, expiration date, and configuration details for the Propofol Injectable Emulsion are provided below. The product batch was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 to July 24, 2020.

product

NDC

A lot of
number

process
date

presentation

Construction/
To count

propofol
Injectable
Emulsion,
100ml individually
patient use
Glass
Fliptop Bottle
Vial:
0409-4699-54 tray:
0409-4699-24
EA7470 JUNE 01, 2023 1g/100ml,
single
patient use
Glass
Fliptop Bottle
tray of 10
units

Pfizer prioritizes patient safety and product quality at every step of the manufacturing and supply chain process. Pfizer has notified the direct recipients in writing to arrange for the return of recalled products.

Wholesalers or hospitals with existing inventory of the recalled lot should cease use, cease distribution and quarantine immediately. If you have further distributed the recalled product, please notify your customers and/or any additional locations that may have received the recalled product. Hospitals/facilities should notify healthcare professionals in your organization of this recall. If you need further assistance, call Sedgwick Inc. at 1-800-805-3093 Monday through Friday between 8 a.m. and 5 p.m. ET.

Healthcare professionals may contact Pfizer with questions about this recall using the information below.

contact center

contact information

area of ​​support

Medical information from Pfizer 1-800-438-1985,
Option 3 (8am to 9pm ET Monday to Friday)
www.pfizermedinfo.com
For medical questions about the product
Drug safety from Pfizer 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 issues encountered with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a report form, then complete and mail it to the address on the pre-addressed form or fax it to 1-800-FDA-0178

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


Company contact information

Consumer:
Sedgwick Inc


product photos