Recall archive / FDA company announcement

Hospira: Propofol Injection Emulsion, USP — FDA announcement Aug 22, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Propofol Injection Emulsion, USP
Reason: Potential presence of visible particulate
Classification: Not supplied
Recalling firm: Hospira, Inc., a Pfizer Company
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: ea1bacb9aaf24f4a

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE -NEW YORK, NY., August 22, 2022 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.; To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.; The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.; 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.; Product \| NDC \| Lot Number \| Expiration Date \| Presentation \| Configuration/ Count; Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial \| Vial: 0409-4699-54 Tray: 0409-4699-24 \| EA7470 \| 01 JUNE 2023 \| 1g/100 mL, Single Patient Use Glass Fliptop Vial \| Tray of 10 Units; 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

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE -NEW YORK, NY., August 22, 2022 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.; To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.; The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.; 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.; Product | NDC | Lot Number | Expiration Date | Presentation | Configuration/ Count; Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial | Vial: 0409-4699-54 Tray: 0409-4699-24 | EA7470 | 01 JUNE 2023 | 1g/100 mL, Single Patient Use Glass Fliptop Vial | Tray of 10 Units; 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

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product	NDC	Lot Number	Expiration Date	Presentation	Configuration/ Count
Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial	Vial: 0409-4699-54 Tray: 0409-4699-24	EA7470	01 JUNE 2023	1g/100 mL, Single Patient Use Glass Fliptop Vial	Tray of 10 Units

FDA company announcement, table 2
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

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Aug 22, 2022
Company announcement date: Aug 22, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.