# FDA recall D-0054-2016

> **Hospira Inc.** · Class III · drug recall initiated 2015-09-29.

## Product

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0054-2016
- **Recalling firm:** Hospira Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2015-09-29
- **Report date:** 2015-10-28

- **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-0054-2016

## Citation

> AI Analytics. FDA recall D-0054-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0054-2016. Source: US FDA. Licensed CC0.

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