Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Foreign particle contamination of several products used to treat rare, serious and life-threatening diseases has prompted a warning by the Food and Drug Administration (FDA). The warning includes products made by Genzyme and marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme and Thyrogen – used to treat serious conditions such as Gaucher Disease and thyroid cancer. The foreign particles found in the medications include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

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A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.

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The anesthetic that may be linked to the death of pop star Michael Jackson has been recalled by the Food and Drug Association (FDA) due to the presence of elevated endotoxin levels that may be linked to severe adverse reactions in patients following use of the drug. Teva Pharmaceuticals announced it is recalling specific lots of propofol injectable emulsion, 10 mg/mL 100 mL vials after it was notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms.

Adverse health events such as fever, chills, or rigors are possible with exposure to products with high endotoxin levels. Serious adverse effects, such as disseminated intravascular coagulapathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to products with high endotoxin levels. Affected lots of propofol injectable emulsion include numbers 31305429B and 31305430B.

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