Baxter International Inc., is recalling one shipment from a single lot of the intravenous nutritional supplement Intralipid 20% IV Fat Emulsion distributed from Aug. 8 to Aug. 31, 2017, to hospitals and health care providers because the product has been exposed to subfreezing temperatures during transit to a distribution facility, the Food and Drug Administration announced in a Recall Notice.
If Intralipid 20% IV Fat Emulsion is accidentally frozen, the emulsion droplets will increase in size and form 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 adverse events or complaints related to this recall.
Intralipid 20% IV Fat Emulsion is a prescription product used as a source of calories and essential fatty acids for patients who require parenteral nutrition for extended periods of time. The product is packaged in 100 mL bags. Affected Intralipid 20% IV Fat Emulsion, 100 mL has the product code 2B6061, the lot number 10LE9597, the expiration date 4/1/2019, and the NDC 0338-0519-58.
Baxter has informed its customers of the recall and advised them to remove the affected lot from their supply. Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice