FDA recall D-623-2013

Baxter Healthcare Corp. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11

Reason for recall

Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.

Distribution

Nationwide and Singapore

Key facts

Status: Terminated
Initiation date: 2013-02-27
Report date: 2013-07-03
Termination date: 2015-05-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-623-2013