Medicine recalls
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| The United States: Baxter initiates voluntary nationwide recall of one shipment of Intralipid 20% IV Fat Emulsion due to product being exposed to subfreezing temperatures |
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The US Food and Drug Administration (FDA) announces that Baxter International Inc. is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100ml, distributed between 11 Aug 2017 and 31 Aug 2017 to hospitals and healthcare providers in the United States, to the user level (Lot number: 10LE9597; Expiration Date 1 Apr 2019). 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 100ml bags.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm579212.htm
In Hong Kong, Intralipid Inj 20% (HK-35421) is a pharmaceutical product registered by Fresenius Kabi Hong Kong Limited (Fresenius Kabi), and is a prescription only medicine. As confirmed with Fresenius Kabi, the affected 100ml bag is not a registered pack size and has not been imported into Hong Kong.
Ends/Friday, Oct 6, 2017
Issued at HKT 16:00
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