FDA Drug Class II — Moderate

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.

Hazard

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

Products

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.
Brand
Baxter Healthcare Corporation
UPC
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017

Units Affected

30,910 bags