FDA-Drug2022-09-21Class I

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

Pfizer Inc.
Hazard

Presence of particulate matter

Sold states
USA Nationwide
Affected count
5,390 vials
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1540-2022

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