drugs Class II Updated 2014-01-29

Fresenius Kabi USA, LLC recalls Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx on

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014) NDC: 14789-500-10; 122911 (12/2013), 123011 (12/2013)
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