FDA recall D-0276-2015

Product

Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03

Reason for recall

Subpotent Drug: Heparin raw material was found to have low potency

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-10-30

Report date

2014-12-03

Termination date

2016-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2015