Product: 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.
Reason for recall: Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Recall initiated: 20141223
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated