Highest risk U.S. Food and Drug Administration

Baxter Heparin Sodium in 0.9% Sodium Chloride Injection recall: Elevated endotoxin levels

Recall published 2+ years ago

Elevated endotoxin levels

Baxter Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
August 5, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Baxter
Product type
Prescription & OTC drugs

Products covered by this recall

Heparin Sodium in 0.9% Sodium Chloride Injection

What the company announced

FOR IMMEDIATE RELEASE - DEERFIELD, Ill., AUG. 5, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.

Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.

Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 mL in VIAFLEX Plus Plastic Container-1 unit per pouch. This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the product image below for more on where this information can be found.

  • Product Code: 2B0944 · Product Description: Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 mL · Lot Number: N008235 · Expiry Date: 31-Aug-2024 · NDC Number: 0338-0433-04

Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the Urgent Drug Recall letter to return the affected product. Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options.

Contacting Baxter Product Surveillance at the Baxter product feedback portal at https://productfeedback.baxter.com or emailing Baxter at [email protected] .

Reporting to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Investor Contact

Clare Trachtman, (224) 948-3020

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • N008235

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 31-Aug-2024

Model or item number

On the rating label, the box or the instruction sheet.

  • 2B0944

Package size

Match the net weight or the piece count on the front of the pack.

  • 000 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Chemical

Baxter — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  3. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  4. Ventilate the room if the product was sprayed or applied there.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: Baxter International Inc — Consumers: Baxter Healthcare Center for Service, (888)-229-0001 — Media: Andrea Johnson, (224) 948-5353, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Baxter prescription & otc drugs recalled?

Elevated endotoxin levels Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code N008235; best-by date 31-Aug-2024; model number 2B0944. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

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