Reported Jan 29, 2014 · Terminated
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC |
| 2 | Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA |
| 3 | for Nexus Pharmaceuticals Inc |
| 4 | Vernon Hills, IL 60061. NDC 14789-500-10. |
- Lot codes and dates
- 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
14789-500-10122911 (12/2013)123011 (12/2013)
- Amount recalled
- 121,456 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
This product could cause temporary or reversible health problems — stop using it.
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