Fluconazole Injection recalled over sterility concerns

Recall date

December 23, 2014

Source

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

Official notice title

Baxter Healthcare Corp. recalls Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL…

Recall number

D-0380-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide, United Arab Emirates, and Columbia

Why it was recalled

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

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 (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.