# FDA recall D-0245-2021

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2020-12-23.

## Product

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

## Reason for recall

Presence of Particulate Matter - found in reserve sample vials at the firm.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0245-2021
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-23
- **Report date:** 2021-02-03
- **Termination date:** 2023-06-09

- **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-0245-2021

## Citation

> AI Analytics. FDA recall D-0245-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0245-2021. Source: US FDA. Licensed CC0.

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