# FDA recall D-1500-2016

> **Hospira Inc.** · Class II · drug recall initiated 2016-08-15.

## Product

DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

## Reason for recall

Discoloration: Firm received complaints of product discoloration and particulates.

## Distribution

Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units.  30 units returned by customer and destroyed internally.

## Key facts

- **Recall number:** D-1500-2016
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-15
- **Report date:** 2016-09-21
- **Termination date:** 2019-08-23

- **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-1500-2016

## Citation

> AI Analytics. FDA recall D-1500-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1500-2016. Source: US FDA. Licensed CC0.

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