FDA recall D-368-2014

Product

10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.

Reason for recall

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-12

Report date

2013-12-25

Termination date

2015-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-368-2014