Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx...
FDA Recall #D-0206-2017 — Class II — December 6, 2016
Product Description
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30,910 bags
Distribution
United States, United Arab Emirates, and Colombia
Code Information
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated