# FDA recall D-1489-2019

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2019-06-28.

## Product

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by:  Fresenius Kabi, Lake Zurich, IL 60047.  63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

## Reason for recall

Presence of Particulate Matter; glass particulates

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1489-2019
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-28
- **Report date:** 2019-07-24
- **Termination date:** 2022-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Melrose Park, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2019

## Citation

> AI Analytics. FDA recall D-1489-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1489-2019. Source: US FDA. Licensed CC0.

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