FDA recall D-0216-2019

Product

0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045

Reason for recall

Lack of Assurance of Sterility; bags have the potential to leak

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2018-10-08

Report date

2018-11-14

Termination date

2021-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

LAKE FOREST, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2019