FDA recall D-1131-2015

Product

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

Reason for recall

Subpotent Drug; out of specification results for heparin raw material

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-03

Report date

2015-06-17

Termination date

2017-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1131-2015