# FDA recall D-0172-2021

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2020-12-10.

## Product

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

## Reason for recall

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0172-2021
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-10
- **Report date:** 2020-12-30
- **Termination date:** 2022-08-25

- **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-0172-2021

## Citation

> MORVS. FDA recall D-0172-2021. Retrieved 2026-11-02 from https://api.morvs.ai/recall/D-0172-2021. Source: US FDA. Licensed CC0.

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