Fluconazole Injection recalled over sterility concerns

Recall date

December 6, 2016

Source

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

Official notice title

Baxter Healthcare Corporation recalls Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthca…

Recall number

D-0206-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

United States, United Arab Emirates, and Colombia

Why it was recalled

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

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

What was recalled

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.