Intralipid 20% recalled over temperature-control failures

Recall date

September 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Baxter Healthcare Corporation recalls Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxte…

Recall number

D-0030-2018

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.

Why it was recalled

Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58