PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 21, 2022 Initiated: August 22, 2022 #D-1540-2022

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

Details

Recalling Firm
Pfizer Inc.
Units Affected
5,390 vials
Distribution
USA Nationwide
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 5,390 vials.
Why was this product recalled?
Presence of particulate matter
Which agency issued this recall?
This recall was issued by the FDA Drug on September 21, 2022. Severity: Critical. Recall number: D-1540-2022.