Recall: D-0380-2015

Class II - Potentially Harmful

Class IIClassification

2014-12-23Initiated

TerminatedStatus

Baxter Healthcare Corp.Firm

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.

Reason

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

Distribution

Nationwide, United Arab Emirates, and Columbia

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