D-1540-2022 Class I Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-1540-2022 was initiated by Pfizer Inc. on Aug 22, 2022 and is designated Class I. Reason for recall: Presence of particulate matter The recall status is terminated (terminated Jun 30, 2025). Affected quantity: 5,390 vials.

Recall Details

Product Type
Drugs
Report Date
Sep 21, 2022
Initiation Date
Aug 22, 2022
Termination Date
Jun 30, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,390 vials

Product Description

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Reason for Recall

Presence of particulate matter

Distribution Pattern

USA Nationwide

Code Information

Lot#: EA7470, Exp 6/1/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1540-2022
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.