PlainRecalls
FDA Drug Moderate Class II Terminated

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.

Reported: December 3, 2014 Initiated: October 14, 2014 #D-0280-2015

Product Description

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.

Reason for Recall

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Details

Recalling Firm
Hospira Inc.
Units Affected
823,296 bags
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.. Recalled by Hospira Inc.. Units affected: 823,296 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 3, 2014. Severity: Moderate. Recall number: D-0280-2015.