FDA recall D-263-2013

Hospira Inc. · Class I · drug

Product

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

Reason for recall

Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-10-05
Report date
2013-04-24
Termination date
2015-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-263-2013