PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 3, 2016 Initiated: September 18, 2015 #D-0618-2016

Product Description

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.

Details

Recalling Firm
Sentara Enterprises
Units Affected
a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags
Distribution
U.S. Including: VA, NC
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sentara Enterprises. Units affected: a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags.
Why was this product recalled?
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 3, 2016. Severity: Moderate. Recall number: D-0618-2016.