Intralipid Intravenous Fat Emulsion Recalled for Temperature Abuse
McKesson Medical-Surgical is recalling Intralipid intravenous fat emulsion distributed nationwide due to cGMP deviations involving temperature abuse that could compromise product safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a high-risk intravenous product affected by cGMP deviations. The recall qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric. No illnesses or injuries have been documented.
Plain-English summary
Intralipid (intravenous fat emulsion), 20%, 250 mL bags, is a prescription medication manufactured by Baxter Healthcare and distributed by McKesson Medical-Surgical. Five cases of this product are being recalled.
The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. Temperature excursions can potentially compromise the stability and safety of intravenous medications.
The product was distributed nationwide in the United States. Healthcare facilities and providers are advised to check whether they received affected product.
Customers who received this product should contact McKesson Medical-Surgical for additional information. McKesson is unable to identify specific lot numbers by consignee; instead, facilities should reference the distribution dates provided in recall letters to determine whether they received affected product.
The recalled product
- Product
- INTRALIPID (I.V. FAT EMULSION)
- Brand
- INTRALIPID
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- cgmp-deviation
Distribution
Distributed nationwide across the United States.
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