PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 29, 2015 Initiated: April 7, 2015 #D-0490-2015

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

Reason for Recall

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

Details

Recalling Firm
Hospira Inc.
Units Affected
128,050 ADD-Vantage flexible containers
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 128,050 ADD-Vantage flexible containers.
Why was this product recalled?
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 29, 2015. Severity: Moderate. Recall number: D-0490-2015.