Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, p...
FDA Recall #D-0380-2015 — Class II — December 23, 2014
Product Description
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.
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
31,130 bags
Distribution
Nationwide, United Arab Emirates, and Columbia
Code Information
Lot #: P318394; Exp 05/31/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated