FDA recall D-0392-2015

Product

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

Reason for recall

Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-10

Report date

2015-02-25

Termination date

2015-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2015