FDA-Drug2016-12-28Class II
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.
Baxter Healthcare Corporation
Hazard
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Sold states
United States, United Arab Emirates, and Colombia
Affected count
30,910 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0206-2017Don't want to check this manually?
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