FDAFDA · Food and drugs·Recall number D-0380-2015
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.
Published February 4, 2015 · Recall initiated: December 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUCONAZOLE
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Nationwide, United Arab Emirates, and Columbia
- Lot
- Lot #: P318394; Exp 05/31/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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