FDA recall D-1190-2018

Product

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31

Reason for recall

cGMP Deviation

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2018-09-06

Report date

2018-09-26

Termination date

2020-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1190-2018