Intralipid IV Fat Emulsion Recalled for Temperature Abuse During Manufacturing
Intralipid intravenous fat emulsion is being recalled due to cGMP manufacturing deviations involving temperature abuse. The product was distributed nationwide.
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: FDA Class II recall for temperature-related cGMP deviations involving a sterile intravenous product. Although no illnesses or injuries have been reported, temperature abuse during manufacturing of a parenteral medication poses a risk of harm should the product's sterility be compromised.
Plain-English summary
Intralipid (I.V. Fat Emulsion), 20%, 100 mL bags manufactured by Baxter Healthcare Corporation and distributed by McKesson Medical-Surgical Inc. is subject to recall.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during the manufacturing process.
The product was distributed nationwide in 2 cases. Due to the manner in which the product was distributed, McKesson Medical-Surgical was unable to identify the specific lot numbers for each consignee. Customers received letters indicating the distribution date and the date range when affected product may have been shipped to them.
The recalled product
- Product
- INTRALIPID (I.V. FAT EMULSION)
- Brand
- INTRALIPID
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Intravenous Emulsion
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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