FDA recall D-0881-2018

Product

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

Reason for recall

Lack of assurance of sterility: Bags have potential to leak.

Distribution

Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2018-05-31

Report date

2018-06-27

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

LAKE FOREST, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0881-2018