Heparin Recall Issued by FDA

The FDA announced an urgent drug recall this week regarding Heparin injections. The drug, indicated for the prevention of blood clots, may contain dangerous levels of endotoxins. The affected lot includes Heparin Sodium in 0.9% Sodium Chloride solution, 2,000 units per 1,000 mL. The medication is used to maintain catheter patency and is typically administered by a healthcare professional. Patients and healthcare professionals alike must be diligent in checking Heparin injections prior to use.

As of the writing of this notice, Baxter International, Inc., the drug manufacturer, has not received any reports of adverse events related to this recall.  

SUMMARY

Date of Recall:

Announced: August 5, 2024

Public Notification: August 6, 2024

Name(s) of Drug:

Heparin Sodium in 0.9% Sodium Chloride solution, 2,000 units per 1,000 mL

Company Name:

Baxter International, Inc.

Drug Indication:

Blood clot prevention

Product Description

Heparin injections are available by prescription only. The solution was distributed to medical facilities nationwide in 1,000mL Viaflex Plus plastic containers. The white label contains the drug name and strength, lot number, expiration date, and relevant codes.

Reason for Recall

During bacterial endotoxin testing, the FDA noted higher-than-acceptable levels of endotoxins in the sample from this lot. Endotoxins are found within bacteria’s cell walls and can elicit dangerous reactions in patients.

Impacts

When a person is exposed to an endotoxin, their body may react similarly to how it would to the bacteria itself. This is extremely dangerous and may lead to symptoms such as:

• Fever
• Low Blood Pressure
• High Heart Rate
• Organ Failure
• Anaphylaxis
• Death

This is especially dangerous for patients who are immunocompromised or who are receiving treatment for an acute or chronic condition.

Recall Product Information

Consumers who are set to receive an IV (intravenous) injection of Heparin should ask the healthcare provider to double-check the packaging carefully. You can also ask to verify the label yourself prior to receiving the injection. Healthcare providers should diligently confirm the label on all Heparin injection packaging to ensure the recalled infusion is not administered.

All facility stock must be thoroughly examined and affected stock removed immediately.

www.fda.gov

Have you found that you are in possession of drugs included in the recall? Here’s what you should do:

Consumers

1. Ask your healthcare provider to replace the infusion with one not included in the recall.
2. Seek immediate medical attention if you have received the recalled medication.
3. Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
4. If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. If you have questions, contact Baxter Healthcare Center at (888)-229-0001. They are available from 7:00 to 6:00 pm Central Time, Monday through Friday. You can also reach Baxter by email at corporate_product_complaints_round_lake@baxter.com.
6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock included in the recall.
2. Notify facilities of recalled batches that they have already or will receive.
3. If you have questions, contact Baxter Healthcare Center at (888)-229-0001. They are available from 7:00 to 6:00 pm Central Time, Monday through Friday. You can also reach Baxter by email at corporate_product_complaints_round_lake@baxter.com.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and consider removing stock included in the warning.
2. Notify facilities of recalled batches that they have already or will receive.
3. If you have questions, contact Baxter Healthcare Center at (888)-229-0001. They are available from 7:00 to 6:00 pm Central Time, Monday through Friday. You can also reach Baxter by email at corporate_product_complaints_round_lake@baxter.com.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!