PlainRecalls
FDA Drug Moderate Class II Terminated

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Reported: March 25, 2015 Initiated: March 5, 2015 #D-0417-2015

Product Description

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Reason for Recall

Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Details

Recalling Firm
Hospira Inc.
Units Affected
94,440 bags
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.. Recalled by Hospira Inc.. Units affected: 94,440 bags.
Why was this product recalled?
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 25, 2015. Severity: Moderate. Recall number: D-0417-2015.