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.

Recall Number: D-0206-2017

Firm: Baxter Healthcare Corporation

Classification: Class II

Status: Terminated

Report Date: 20161228

Initiation Date: 20161206

Termination Date: 20180212

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

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.