D-1034-2014 Class II Terminated
FDA drug recall D-1034-2014 was initiated by Fresenius Kabi USA, LLC on Oct 31, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. The recall status is terminated (terminated Jan 7, 2016). Affected quantity: 121,456 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 29, 2014
- Initiation Date
- Oct 31, 2013
- Termination Date
- Jan 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121,456 vials
Product Description
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.
Distribution Pattern
US: Nationwide
Code Information
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)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1034-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026