# FDA recall D-0184-2021

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2020-12-17.

## Product

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

## Reason for recall

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

## Distribution

USA Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0184-2021
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-17
- **Report date:** 2021-01-06
- **Termination date:** 2023-06-20

- **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-0184-2021

## Citation

> AI Analytics. FDA recall D-0184-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0184-2021. Source: US FDA. Licensed CC0.

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