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FDA Import Alert

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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Heparin Recall Import Alert: The FDA’s Role

In continuing to educate the public on issues regarding the recall of Heparin products, the FDA published informational charts regarding how the importation of Heparin is regulated. 

Product Entry:
Heparin, including the Active Pharmaceutical Ingredient (API) and finished heparin, enter U.S. ports from overseas.

Import Alert:
The FDA issues an import alert on shipments from specified manufacturer(s) and product(s). If a product is imported from a manufacturer, investigators will detain the shipment.

Industry and FDA Response:
If the industry provides information and the FDA confirms that appropriate corrections have been made, the FDA will remove the manufacturer and product from the import alert.

Safe Product Alert:
The FDA continues to engage with industry to help ensure adequate supply of safe heparin reaches patients.

For additional information from the FDA, click here.

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

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see also:

FDA: Analyzing the Contaminant Recall Alert: FDA Process of Analyzing Heparin Contaminant--Legal Info
Recall in the News: How the FDA Analyzes the Contaminant in Heparin

March 7, 2008 Update The FDA provides an update to questions about the Heparin recall
Recall of Baxter's Heparin prompts updated information from the FDA

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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