FDAClass IIApril 29, 2015

0.9% Sodium Chloride Injection recall: Sterility Concern

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

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Sterility Assurance: The product has the potential to leak at the administrative port.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 44-110-JT; Exp 08/16

Product
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
Recalling firm
Hospira Inc.
Quantity
128,050 ADD-Vantage flexible containers
Distribution
Nationwide
Recall date
April 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls