Drug recall D-0030-2018

Class I Terminated reported Nov 1, 2017

Product

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

Reason for recall

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.

Lots and codes

Lot #: 10LE9597, Exp 04/01/19

Recall details

Recalling firm
Baxter Healthcare Corporation, Deerfield, IL
Quantity
910 bags
Distribution
Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
September 15, 2017
Terminated
September 6, 2018

Related products