FDA recall D-0301-2015

Product

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

Reason for recall

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-11-25

Report date

2014-12-24

Termination date

2015-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2015