Fresenius Kabi USA, LLC recalls Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two la
Recalled January 29, 2014 · FDA recall D-1034-2014 · Fresenius Kabi USA
Hazard
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. · FDA Class II
Units
121,456 vials
Sold at
US: Nationwide
Description
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →