# FDA recall D-0658-2020

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2019-12-17.

## Product

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

## Reason for recall

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0658-2020
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-17
- **Report date:** 2020-01-22
- **Termination date:** 2021-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cherry Hill, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2020

## Citation

> AI Analytics. FDA recall D-0658-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0658-2020. Source: US FDA. Licensed CC0.

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