Drug Enforcement D-262-2013

Non-Sterility: Confirmed customer complaint of product contaminated 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 container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
Product quantity
143,136 flexible containers
Reason for recall
Non-Sterility: Confirmed customer complaint of product contaminated 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-262-2013
Event ID
64197
Recall initiation date
January 25, 2013
Center classification date
April 17, 2013
Code info
Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.
More code info