FDA recall D-0284-2015

Product

Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.

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-0284-2015