# FDA recall D-1391-2020

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2020-07-13.

## Product

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

## Reason for recall

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1391-2020
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-13
- **Report date:** 2020-07-22
- **Termination date:** 2022-08-19

- **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-1391-2020

## Citation

> AI Analytics. FDA recall D-1391-2020. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/D-1391-2020. Source: US FDA. Licensed CC0.

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