FDA recall D-0428-2015

Product

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

Reason for recall

Lack of Assurance of Sterility; increased complaints received for leaks

Distribution

Nationwide and Singapore

Key facts

Status

Terminated

Initiation date

2015-03-23

Report date

2015-04-08

Termination date

2016-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0428-2015