# FDA recall D-0867-2020

> **RemedyRepack Inc.** · Class I · drug recall initiated 2019-12-27.

## Product

Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00

## Reason for recall

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

## Distribution

Product distributed in OK and LA.

## Key facts

- **Recall number:** D-0867-2020
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-27
- **Report date:** 2020-02-19
- **Termination date:** 2020-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0867-2020

## Citation

> AI Analytics. FDA recall D-0867-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0867-2020. Source: US FDA. Licensed CC0.

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