FDA recall D-1425-2014

Product

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

Reason for recall

Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-06-06

Report date

2014-07-16

Termination date

2015-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1425-2014