FDA-Drug2015-03-25Class II

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.

Hospira Inc.
Hazard

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

Sold states
Nationwide
Affected count
94,440 bags
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0417-2015

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