# FDA recall D-0120-2021

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2020-11-17.

## Product

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

## Reason for recall

Cross Contamination with other products: trace amounts of lidocaine

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0120-2021
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-17
- **Report date:** 2020-12-16
- **Termination date:** 2022-09-12

- **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-0120-2021

## Citation

> AI Analytics. FDA recall D-0120-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0120-2021. Source: US FDA. Licensed CC0.

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