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Just before Christmas in 2007, AM2 PAT, Inc. (also known as Sierra Pre-Filled) recalled one lot of pre-filled Heparin flush syringes. It was confirmed a month later that the lot was contaminated with a rare bacteria known as Serratia marcescens. As a result, the FDA announced a nationwide recall of all Heparin manufactured by AM2 PAT, Inc.
Symptoms associated with the bacterial contaminated lot of AM2 PAT, Inc. Heparin include:
Baxter Healthcare Corporation is another major manufacturer of Heparin. Between January and February of 2008, Baxter recalled all of the lots of the drug it produced due to reports of side-effects including:
After an investigation in March, 2008, the FDA identified the contaminant in Baxter's Heparin as over-sulfated chondroitin sulfate-a common and inexpensive dietary supplement, which is derived from animals. The supplement was supplied to Baxter by the Scientific Protein Laboratories in Wisconson, and mimics Heparin when it's chemically altered. Ultimately, the contaminant was traced as far back as a manufacturing plant in China.
As of April of 2008, over 60 possible contaminated-Heparin deaths have been reported to the FDA. Baxter manufactured approximately 50 percent of the Heparin used in the U.S.
General reactions to Heparin and side effects have included any or all of the following:
Heparin manufacturers have admitted that these effects can be severe or life-threatening.
If you or someone you know was hospitalized, died or is currently experiencing any of the above side effects, please call the Anderson Law Firm for a free consultation at 817-294-1900 or Contact Us Online.
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