Product: 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.
Reason for recall: Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Recall initiated: 20161206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated