FDA recall D-1159-2014

Product

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.

Reason for recall

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-18

Report date

2014-03-26

Termination date

2016-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1159-2014