FDAFDA · Food and drugs·Recall number D-0030-2018
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
Published November 1, 2017 · Recall initiated: September 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- INTRALIPID
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.
- Lot
- Lot #: 10LE9597, Exp 04/01/19
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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