FDA recall D-0285-2015

Hospira Inc. · Class II · drug

Product

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

Reason for recall

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Distribution

Nationwide, Puerto Rico, and U.S. Virgin Islands.

Key facts

Status
Terminated
Initiation date
2014-10-14
Report date
2014-12-03
Termination date
2015-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0285-2015