# FDA recall D-0618-2016

> **Sentara Enterprises** · Class II · drug recall initiated 2015-09-18.

## Product

INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

## Reason for recall

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

## Distribution

U.S. Including: VA, NC

## Key facts

- **Recall number:** D-0618-2016
- **Recalling firm:** Sentara Enterprises
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-18
- **Report date:** 2016-02-03
- **Termination date:** 2016-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chesapeake, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2016

## Citation

> AI Analytics. FDA recall D-0618-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0618-2016. Source: US FDA. Licensed CC0.

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