Recall of Baxter intralipid 20 percent IV fat emulsion due to subfreezing temperature exposure

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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” FDA (2017).

FDA report “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.”

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