# FDA recall D-0381-2015

> **Hospira Inc.** · Class II · drug recall initiated 2014-12-23.

## Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

## Reason for recall

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0381-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-23
- **Report date:** 2015-02-04
- **Termination date:** 2015-07-30

- **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-0381-2015

## Citation

> AI Analytics. FDA recall D-0381-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0381-2015. Source: US FDA. Licensed CC0.

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