FDA recall D-0731-201

Baxter Healthcare Corp. · Class II · drug

Product

0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03

Reason for recall

PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-02-05
Report date: 2016-03-09
Termination date: 2016-11-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0731-201