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FDA (Drug enforcement)Recalled 2017-09-15closedclass i

Baxter Healthcare Corporation: 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,

Is my product affected?

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

  • Brand INTRALIPID

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling Intralipid 20%, a 20% intravenous fat emulsion supplied in 100 milliliter bags. The product in question is lot #10LE9597 with an expiration date of April 1, 2019. During shipment to a distribution facility, a portion of this lot was exposed to subfreezing temperatures, which falls outside the acceptable storage range specified on the product label. A total of 910 bags were affected by this temperature exposure.

The impacted shipment was distributed to wholesalers, medical facilities, and physicians in California and Nevada, though it is possible the product may have been distributed further throughout the United States. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA. Quantity: 910 bags Lot/code info: Lot #: 10LE9597, Exp 04/01/19

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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