# FDA recall D-0625-2016

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

## Product

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML 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-0625-2016
- **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-0625-2016

## Citation

> AI Analytics. FDA recall D-0625-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0625-2016. Source: US FDA. Licensed CC0.

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