FDA recall D-0972-2017

Baxter Healthcare Corporation · Class II · drug

Product

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

Reason for recall

Lack of Assurance of Sterility: Bags have the potential to leak.

Distribution

Nationwide, Puerto Rico and Saudi Arabia

Key facts

Status
Terminated
Initiation date
2017-07-06
Report date
2017-07-19
Termination date
2020-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0972-2017