FDA recall D-0618-2016

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

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

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