# FDA recall D-1124-2017

> **Amphastar Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-08-15.

## Product

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

## Reason for recall

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

## Distribution

Distributed throughout the United States

## Key facts

- **Recall number:** D-1124-2017
- **Recalling firm:** Amphastar Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-15
- **Report date:** 2017-09-06
- **Termination date:** 2019-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rancho Cucamonga, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2017

## Citation

> AI Analytics. FDA recall D-1124-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1124-2017. Source: US FDA. Licensed CC0.

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