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
Product summary
- 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
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.