# FDA recall D-1176-2017

> **RemedyRepack Inc.** · Class II · drug recall initiated 2017-08-22.

## Product

Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA  91730.

## Reason for recall

Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.

## Distribution

Product was distributed to one consignee in Louisiana.

## Key facts

- **Recall number:** D-1176-2017
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2017-10-04
- **Termination date:** 2018-01-03

- **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-1176-2017

## Citation

> AI Analytics. FDA recall D-1176-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1176-2017. Source: US FDA. Licensed CC0.

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