FDA recall D-184-2013

Product

HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54

Reason for recall

Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-10-22

Report date

2013-03-13

Termination date

2015-03-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-184-2013