FDA recall D-1301-2022

Product

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per 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: particulate identified as a beetle.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-07-13

Report date

2022-08-03

Termination date

2024-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1301-2022