Recalls / Class II
Class IID-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.
- Brand name
- Tranexamic Acid
- Generic name
- Tranexamic Acid
- Active ingredient
- Tranexamic Acid
- Route
- Intravenous
- NDC
- 63323-563
- FDA application
- ANDA091596
- Affected 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)
Why it was recalled
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 121,456 vials
- Distribution pattern
- US: Nationwide
Timeline
- Recall initiated
- 2013-10-31
- FDA classified
- 2014-01-23
- Posted by FDA
- 2014-01-29
- Terminated
- 2016-01-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1034-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.