Drug Enforcement D-613-2013

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
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
Product quantity
136,584 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-613-2013
Event ID
61918
Recall initiation date
May 4, 2012
Center classification date
June 21, 2013
Code info
Lot #: 93-153-JT, Exp 9/12
More code info