FDA Issues Recall of Heparin

Texas Heparin Lawsuit Lawyers

Heparin is a widely used blood thinner that has been available in the U.S. since the 1930's. It is used for many health conditions but most commonly used to prevent blood clots in patients undergoing kidney dialysis and heart surgery. It is also given to people who have deep vein thrombosis or pulmonary embolism. These conditions usually require large doses to be given. It is made in lower doses which are used to flush out catheter lines. Heparin is made by different drug companies. Since the end of December, there have been recalls and about 350 reports of adverse reactions and 4 deaths associated with Baxter's heparin product. Reported reactions include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, headache, loss of consciousness, malaise, nausea and other allergic reactions. Another drug company AM2 PAT, Inc., or B. Braun notified healthcare professionals and patients on January 18, 2008 of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Serratia marcescens which has resulted in patient infections. This type of bacterial infection can present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

For a complete list of the recalled products, see the Recall Notice.

[January 30, 2008 - Class 1 Recall - FDA]
[January 25, 2008 - News Release - FDA]
[January 18, 2008 - Press Release - AM2 PAT, Inc.]
[January 18, 2008 - Press Release - B. Braun]

http://www.fda.gov/medwatch/safety/2008/Heparin_recall_01-17-2008.pdf.

Learn Your Legal Rights

If you or someone you know has taken these medications and has suffered injury, side effects or death, you should contact our office immediately to learn about and protect your legal rights.

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