FDA recall D-0206-2017

Product

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.

Reason for recall

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Distribution

United States, United Arab Emirates, and Colombia

Key facts

Status

Terminated

Initiation date

2016-12-06

Report date

2016-12-28

Termination date

2018-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0206-2017