drugs Class II Updated 2015-02-04

Baxter Healthcare Corp. recalls Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL

Recalled 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.

Hazard / Issue

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: P318394; Exp 05/31/16
View official government recall

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