FDA recall D-0380-2015

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.

Reason for recall

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

Distribution

Nationwide, United Arab Emirates, and Columbia

Key facts

Status

Terminated

Initiation date

2014-12-23

Report date

2015-02-04

Termination date

2016-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2015