Drug Enforcement D-615-2013

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Status

Terminated

Classification

Class II

Report Date

July 3, 2013

Termination Date

July 17, 2015

Product Information

Product description
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Product quantity
74,256 units
Reason for recall
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia

Location & Firm

Recalling firm
Hospira Inc.
Address
275 N Field Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-615-2013
Event ID
61918
Recall initiation date
May 4, 2012
Center classification date
June 21, 2013
Code info
Lot #: 11-161-JT, Exp 11/13
More code info