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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
- Affected units
- 2
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
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