# FDA recall D-1685-2012

> **Hospira Inc.** · Class II · drug recall initiated 2012-08-29.

## Product

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA

## Reason for recall

Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1685-2012
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-29
- **Report date:** 2012-10-03
- **Termination date:** 2013-08-08

- **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-1685-2012

## Citation

> AI Analytics. FDA recall D-1685-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1685-2012. Source: US FDA. Licensed CC0.

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