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Baxter Initiates Voluntary Nationwide Recall Of One Shipment of Intralipid 20% IV Fat Emulsion Due To Product Being Exposed To Subfreezing Temperatures

Last updated Nov. 6, 2017

Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level.


Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue.

If accidentally frozen, INTRALIPID 20% IV Fat Emulsion should not be used. When subjected to freezing, the emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life-threatening. To date, Baxter has not received any reports of associated adverse events or product complaints.  INTRALIPID 20% IV Fat Emulsion is a prescription product indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of times. The product is packaged in 100 mL bags.

This recall affects one shipment of the following lot:

Product Code
Product Description
Lot Number
Expiration Date
NDC
2B6061
INTRALIPID 20% IV Fat Emulsion, 100 mL
10LE9597
4/1/2019
0338-0519-58


Baxter has informed customers affected by this particular shipment to locate and remove all affected product.  Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.

Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8 a.m. and 5 p.m. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Baxter is voluntarily conducting this recall with the knowledge of the U.S. Food and Drug Administration.


Materials provided by U.S Food and Drug AdministrationNote: Content may be edited for style and length.

Disclaimer: DoveMed is not responsible for the accuracy of the adapted version of news releases posted to DoveMed by contributing universities and institutions.

References:

Affairs, O. O. (n.d.). Recalls, Market Withdrawals, & Safety Alerts - Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures. Retrieved November 06, 2017, from https://www.fda.gov/Safety/Recalls/ucm579212.htm

Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: Nov. 6, 2017
Last updated: Nov. 6, 2017