Recall: D-0788-2017
Class II - Potentially Harmful
Class IIClassification
2017-05-15Initiated
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: customer complaints received for the presence of leaks.
Distribution
US and foreign countries: United Arab Emirates, Colombia, and Canada
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.