FDA recall D-0384-2021

Product

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

Reason for recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2021-05-03

Report date

2021-05-26

Termination date

2023-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2021