FDA recall D-0788-2017

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: customer complaints received for the presence of leaks.

Distribution

US and foreign countries: United Arab Emirates, Colombia, and Canada

Key facts

Status

Terminated

Initiation date

2017-05-15

Report date

2017-05-24

Termination date

2018-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2017