FDA recall D-1128-2018

Product

0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

Reason for recall

CGMP Deviations

Distribution

TX and MS only

Key facts

Status

Terminated

Initiation date

2018-08-21

Report date

2018-09-05

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1128-2018