Drug Enforcement D-836-2013

Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates

Status

Terminated

Classification

Class I

Report Date

August 14, 2013

Termination Date

July 20, 2015

Product Information

Product description
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Product quantity
691,356 containers
Reason for recall
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
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-836-2013
Event ID
64792
Recall initiation date
March 29, 2013
Center classification date
August 2, 2013
Code info
Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90
More code info