FDAFDA · Food and drugs·Recall number D-1034-2014
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.
Published January 29, 2014 · Recall initiated: October 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US: Nationwide
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.