Drug Enforcement D-263-2013

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

Status

Terminated

Classification

Class I

Report Date

April 24, 2013

Termination Date

August 21, 2015

Product Information

Product description
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Product quantity
136,224 flexible containers
Reason for recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Recall initiation reason
Initial firm notification
Press Release
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Hospira Inc.
Address
275 N Field Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-263-2013
Event ID
63432
Recall initiation date
October 5, 2012
Center classification date
April 17, 2013
Code info
Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
More code info