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Recall Observatory FDA recall evidence

Drug product

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

D-0030-2018

September 15, 2017

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 78155
Status
Terminated
Classification
Class I
Quantity
910 bags
Official record key
drug-enforcement:D-0030-2018

Official wording

Reason: 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.

Code information: Lot #: 10LE9597, Exp 04/01/19

Distribution pattern: Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.