CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
Tranexamic Acid Injection USP, 1000mg/ vial recalled
Fresenius Kabi USA is recalling Tranexamic Acid Injection USP, 1000mg/ vial, distributed nationwide in the US. The recall was initiated on 31 Oct 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1034-2014
- FDA event ID
- 66678
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Oct 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Oct 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +84 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Product as listed by the FDA
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.
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Which lots are affected?
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)
Where was it sold?
US: Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
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|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Tranexamic Acid recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS III | Lysteda (tranexamic acid) USP Tablets, 650 mg recalledTranexamic Acid | Amring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS II | Tranexamic Acid* Solution recalled by Specialty Medicine | Specialty Medicine Compounding Pharmacy | Sterility | MI |