FDA-Drug2015-02-04Class II
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.
Baxter Healthcare Corp.
Hazard
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Sold states
Nationwide, United Arab Emirates, and Columbia
Affected count
31,130 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2015Don't want to check this manually?
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