# FDA recall D-0614-2016

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

## Product

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML 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-0614-2016
- **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-0614-2016

## Citation

> AI Analytics. FDA recall D-0614-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0614-2016. Source: US FDA. Licensed CC0.

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