September 2017 FDA Recall Intralipid by Baxter Healthcare Corporation
D-0030-2018 - Temperature Abuse

This Class I drug recall was voluntarily initiated by Baxter Healthcare Corporation on September 15, 2017 for the product Intralipid. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0030-2018

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.
Initiated
09-15-2017
Reported
11-01-2017
Quantity
910 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78155
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-06-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0338-0519-58 Intralipid
0338-0519-09 Intralipid
0338-0519-13 Intralipid