Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Intralipid 20% I.V. Fat Emulsion Recalled for Potential Temperature Abuse

Agency Publication Date: October 24, 2017

Summary

Baxter Healthcare Corporation is recalling 910 bags of Intralipid 20% (A 20% I.V. Fat Emulsion), a nutritional supplement delivered intravenously. This recall was initiated because a portion of the product lot was exposed to subfreezing temperatures during transit to a distribution facility. Exposure to temperatures outside the required storage range can cause the fat emulsion to break down, potentially making the medication unsafe or ineffective for patients.

Risk

Exposure to freezing temperatures can compromise the stability of the fat emulsion. Administering a degraded product intravenously could lead to serious adverse health consequences or reduced therapeutic benefits for patients requiring nutritional support.

What You Should Do

Check your medical supplies for Intralipid 20% (A 20% I.V. Fat Emulsion) in 100 ml bags with NDC 0338-0519-58.
Identify if your product is affected by looking for Lot Number 10LE9597 and an expiration date of 04/01/19 on the product labeling.
Immediately stop using or administering any products from this specific lot number.
Contact your healthcare provider or pharmacist for guidance if you or a patient have already used medication from the affected lot.
Return any unused product from Lot 10LE9597 to the place of purchase for a refund and contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, 60015-4625 for further instructions.
For additional information or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Intralipid 20%, A 20% I.V. Fat Emulsion (100 ml bag)

Model:

NDC 0338-0519-58

Recall #: D-0030-2018

Lot Numbers:

10LE9597 (Exp 04/01/19)

Date Ranges: 04/01/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78155

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Wholesalers; Medical Facilities; Physicians

Manufactured In: Sweden

Units Affected: 910 bags

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Intralipid 20% (A 20% I.V. Fat Emulsion) in 100 ml bags with NDC 0338-0519-58.

Identify if your product is affected by looking for Lot Number 10LE9597 and an expiration date of 04/01/19 on the product labeling.

Immediately stop using or administering any products from this specific lot number.

Contact your healthcare provider or pharmacist for guidance if you or a patient have already used medication from the affected lot.

Return any unused product from Lot 10LE9597 to the place of purchase for a refund and contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, 60015-4625 for further instructions.

For additional information or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.