Recall: D-0206-2017

Class II - Potentially Harmful

Class IIClassification

2016-12-06Initiated

TerminatedStatus

Baxter Healthcare CorporationFirm

Product

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

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

Distribution

United States, United Arab Emirates, and Colombia

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.