FDA recall D-1036-2014

Hospira Inc. · Class II · drug

Product

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.

Reason for recall

Lack of Assurance of Sterility; potential leakage from administrative port.

Distribution

Nationwide including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-01-09
Report date: 2014-02-05
Termination date: 2015-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2014