# FDA recall D-0616-2016

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

## Product

Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML 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-0616-2016
- **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-0616-2016

## Citation

> AI Analytics. FDA recall D-0616-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0616-2016. Source: US FDA. Licensed CC0.

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