Tranexamic Acid Injection USP — Class II drug recall D-1034-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-01-29, distributed nationwide. Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
| Recall number | D-1034-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-10-31 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2016-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 121,456 vials |
| Reason classes | foreign material, specification failure |
| NDC | 14789-0500-10, 63323-0563-10 |
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.
Reason for recall
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1034-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.