5% Dextrose Injection recalled over sterility concerns

Recall date

March 18, 2015

Source

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

Official notice title

Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., Nort…

Recall number

D-0426-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

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, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04