Agency classClass IOur severity:Severe FDA (Drugs)·D-0030-2018·Announced 2017-11-01

Baxter Recalls Intralipid Bags Due to Temperature Exposure During Transit

Baxter Healthcare is recalling 910 bags of Intralipid 20% because a portion of the lot was exposed to subfreezing temperatures during transit.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 910 bags of Intralipid (I.V. Fat Emulsion) 20%, 100 ml bags, Lot # 10LE9597, with an expiration date of 04/01/19. The recall was initiated because a portion of this product lot was exposed to subfreezing temperatures during transit to a distribution facility. This temperature exposure is outside the acceptable storage range listed on the product labeling.

The impacted shipment was sent to wholesalers, medical facilities, and physicians in California and Nevada, but could have been further distributed nationwide in the USA. The product is a prescription-only intravenous fat emulsion manufactured by Fresenius Kabi, Uppsala, Sweden, for Baxter Healthcare Corporation.

Healthcare providers and patients should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product: INTRALIPID (I.V. FAT EMULSION)
Brand: INTRALIPID
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Prescription Drug
Hazard: temperature-abuse
Affected units: 910

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 10LE9597
Exp 04/01/19

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same brand · INTRALIPID

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Intralipid Intravenous Fat Emulsion Recalled for Temperature Abuse
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Intralipid IV Fat Emulsion Recalled for Temperature Abuse During Manufacturing
FDA (Drugs) · 2022-06-15

Same manufacturer · Baxter Healthcare Corporation

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