# FDA recall D-0750-2022

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2022-03-04.

## Product

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

## Reason for recall

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0750-2022
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-04
- **Report date:** 2022-03-30
- **Termination date:** 2023-09-29

- **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-0750-2022

## Citation

> AI Analytics. FDA recall D-0750-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0750-2022. Source: US FDA. Licensed CC0.

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