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.
Recall initiated: 20131031
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated