FDAFDA · Food and drugs·Recall number D-0206-2017
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.
Published December 28, 2016 · Recall initiated: December 6, 2016
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: confirmed customer complaints of leaking bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUCONAZOLE
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- United States, United Arab Emirates, and Colombia
- Lot
- Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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