Baxter Healthcare Corp. recalls Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL
Recalled February 4, 2015 · FDA recall D-0380-2015 · Baxter Healthcare
Hazard
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. · FDA Class II
Units
31,130 bags
Sold at
Nationwide, United Arab Emirates, and Columbia
Description
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Product
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.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →