# FDA recall D-0389-2015

> **Hospira Inc.** · Class I · drug recall initiated 2014-10-06.

## Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-4699-30.

## Reason for recall

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

## Distribution

Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

## Key facts

- **Recall number:** D-0389-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-06
- **Report date:** 2015-02-25
- **Termination date:** 2016-12-15

- **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-0389-2015

## Citation

> AI Analytics. FDA recall D-0389-2015. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0389-2015. Source: US FDA. Licensed CC0.

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