Baxter Healthcare product recalled over sterility concerns

Recall date

September 2, 2015

Source

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

Official notice title

Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthca…

Recall number

D-1816-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

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

What was recalled

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38