FDA-Drug2017-05-24Class 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: customer complaints received for the presence of leaks.

Sold states
US and foreign countries: United Arab Emirates, Colombia, and Canada
Affected count
113,590 bags
Manufactured in
1 Baxter Pkwy, 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-0788-2017

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