5% DEXTROSE Injection recalled over sterility concerns

Recall date

March 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hospira Inc. recalls 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 ba…

Recall number

D-0417-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.