Sodium Chloride Injection, Solution
FDA Recall NDC 0409-7101

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Sodium Chloride (NDC 0409-7101). A significant event, classified as Class II, was initiated on Apr 07, 2015 by Hospira, Inc.. The reported reason for this action was: "Lack of Sterility Assurance: The product has the potential to leak at the administrative port."

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0490-2015TERMINATEDD-613-2013TERMINATED

April 2015 Class II Recall: Lack of Sterility Assurance

Recall Number
D-0490-2015
Class II Terminated
Reason for Recall
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Initiated
Apr 07, 2015
Reported
Apr 29, 2015
Quantity
128,050 ADD-Vantage flexible containers

Recall Profile & Regulatory Data

Event ID
70925
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 04, 2016
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
Batch or Lot Expiration Information
Lot# 44-110-JT; Exp 08/16
Affected Packages Involved in this Recall
0409-7101-68Product
0409-7101-66Product
0409-7101-69Product
0409-7101-67Product
0409-7101-04Product
0409-7101-02Product
0409-7132-68Product
0409-7132-66Product
0409-7132-69Product
0409-7132-67Product
0409-7132-04Product
0409-7132-02Product

May 2012 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-613-2013
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Initiated
May 04, 2012
Reported
Jul 03, 2013
Quantity
136,584 units

Recall Profile & Regulatory Data

Event ID
61918
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Termination Date
Jul 17, 2015
Product Description
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
Batch or Lot Expiration Information
Lot# : 93-153-JT, Exp 9/12
Affected Packages Involved in this Recall
0409-7101-68Product
0409-7101-66Product
0409-7101-69Product
0409-7101-67Product
0409-7101-04Product
0409-7101-02Product
0409-7132-68Product
0409-7132-66Product
0409-7132-69Product
0409-7132-67Product
0409-7132-04Product
0409-7132-02Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.