# FDA recall D-1537-2020

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2020-07-22.

## Product

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 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

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1537-2020
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-22
- **Report date:** 2020-09-02
- **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-1537-2020

## Citation

> AI Analytics. FDA recall D-1537-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1537-2020. Source: US FDA. Licensed CC0.

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