# FDA recall D-0651-2021

> **Fresenius Kabi USA LLC** · Class II · drug recall initiated 2021-06-25.

## Product

Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC  63323-487-07, Tray NDC 63323-487-37

## Reason for recall

Low out of specification results for epinephrine assay.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0651-2021
- **Recalling firm:** Fresenius Kabi USA LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-25
- **Report date:** 2021-07-14
- **Termination date:** 2022-12-28

- **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-0651-2021

## Citation

> AI Analytics. FDA recall D-0651-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0651-2021. Source: US FDA. Licensed CC0.

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