# FDA recall D-1297-2020

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2020-04-20.

## Product

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for 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

USA Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1297-2020
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-04-20
- **Report date:** 2020-06-17
- **Termination date:** 2023-10-16

- **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-1297-2020

## Citation

> AI Analytics. FDA recall D-1297-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1297-2020. Source: US FDA. Licensed CC0.

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