# FDA recall D-0482-2015

> **Hospira Inc.** · Class II · drug recall initiated 2015-01-23.

## Product

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

## Reason for recall

Crystallization

## Distribution

U.S. Nationwide and International: Guam and Singapore.

## Key facts

- **Recall number:** D-0482-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-01-23
- **Report date:** 2015-04-15
- **Termination date:** 2016-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0482-2015

## Citation

> AI Analytics. FDA recall D-0482-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0482-2015. Source: US FDA. Licensed CC0.

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