FDA recall D-1034-2014

Product

Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.

Reason for recall

Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.

Distribution

US: Nationwide

Key facts

Status

Terminated

Initiation date

2013-10-31

Report date

2014-01-29

Termination date

2016-01-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1034-2014