FDA recall D-1108-2015

Hospira Inc. · Class I · drug

Product

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

Reason for recall

Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-11
Report date: 2015-06-03
Termination date: 2017-01-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1108-2015