# FDA recall D-1034-2014

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2013-10-31.

## 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.

## Distribution

US: Nationwide

## Key facts

- **Recall number:** D-1034-2014
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-31
- **Report date:** 2014-01-29
- **Termination date:** 2016-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1034-2014

## Citation

> AI Analytics. FDA recall D-1034-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1034-2014. Source: US FDA. Licensed CC0.

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