Fluconazole Injection recalled over sterility concerns

Recall date

May 15, 2017

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-0788-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US and foreign countries: United Arab Emirates, Colombia, and Canada

Why it was recalled

Lack of assurance of sterility: customer complaints received for the presence of leaks.

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