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-0788-2017

Firm: Baxter Healthcare Corporation

Classification: Class II

Status: Terminated

Report Date: 20170524

Initiation Date: 20170515

Termination Date: 20180810

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

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