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Baxter Heparin Label Errors

in this section: FDA Heparin FAQs | Baxter Heparin Label Errors | Heparin Deaths | Heparin Complications | March 7, 2008 Update | Heparin Packaging | FDA Import Alert | FDA: Analyzing the Contaminant | Adverse Reactions | Heparin Warning Letter


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IMPORTANT SAFETY ALERT:
BAXTER HEPARIN SODIUM INJECTION AND HEP-LOCK U/P

February 6, 2007--This important safety information concerns the potential for life threatening medication errors involving two Baxter Heparin products:

Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL.

The currently marketed 1 mL vials of Heparin Sodium Injection 10,000 units/mL and the HEP-LOCK U/P 10 units/mL use shades of blue as the prominent background color on their labels.

Healthcare professionals should be reminded to:
• Never rely on color as a sole indicator to differentiate product identity.
• Always carefully read the product label to verify that the correct product name and strength have been selected.
• Always carefully review both the drug name and dose on the label before dispensing and administering these products.
• Double-check your inventory as soon as possible, to ensure that there is no mix-up of the products.
• Notify all staff of the potential for errors in dispensing and administering these products. It is advised that you provide color photographs (see below) to staff to assist in their understanding of the product similarities.

Baxter provides bar codes on its product labels and is considering ways to differentiate the packaging and labels to decrease the risk of medication errors. While Baxter seeks to more clearly differentiate the appearance of these two products, the Food and Drug Administration (FDA) suggests that your institution review your medication identification and administration policies and procedures. Please ensure that all staff responsible for the dispensing and administration of Heparin Sodium Injection and HEP-LOCK U/P products are aware of these medication errors and that the staff are familiar with your policies and procedures.

If you were harmed after receiving a heparin injection, please complete the form below and a representative of our firm will contact you as soon as possible.

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see also:

Heparin Complications Have you experienced health complications from Heparin? Get Legal Info
Numerous health complications are associated with tainted Heparin

Baxter Heparin Label Errors Important Safety Alert: Baxter Heparin Sodium Injection and Hep-Lock
Baxter Heparin products with blue labeling were accidentally swapped

FDA Health Advisory FDA Issues Advisory on Heparin Due to Health Risks--Free Lawsuit Info
Did You Suffer Adverse Reaction After Heparin Injection? Lawsuit info


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