# FDA recall D-0128-2023

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2022-11-22.

## Product

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

## Reason for recall

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0128-2023
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-11-22
- **Report date:** 2023-01-25
- **Termination date:** 2023-10-23

- **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-0128-2023

## Citation

> AI Analytics. FDA recall D-0128-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0128-2023. Source: US FDA. Licensed CC0.

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