# FDA recall D-0296-2015

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2012-09-27.

## Product

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL),  For IM or IV Use, Single Dose 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

## Reason for recall

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

## Distribution

U.S. Nationwide Including Puerto Rico

## Key facts

- **Recall number:** D-0296-2015
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-27
- **Report date:** 2014-12-17
- **Termination date:** 2014-12-12

- **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-0296-2015

## Citation

> AI Analytics. FDA recall D-0296-2015. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0296-2015. Source: US FDA. Licensed CC0.

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