# FDA recall D-1386-2019

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2019-05-22.

## Product

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1386-2019
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-22
- **Report date:** 2019-06-19
- **Termination date:** 2021-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Island, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1386-2019

## Citation

> AI Analytics. FDA recall D-1386-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1386-2019. Source: US FDA. Licensed CC0.

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