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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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