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A weight loss dietary supplement is being recalled by the Food and Drug Administration (FDA) after an FDA analysis found the supplements contain the presence of undeclared drug ingredients, including a suspected cancer-causing agent. The recalled supplement is made by GMP Herbal Products and is marketed under the name Pai You Guo.
A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.
External biphasic defibrillators, monitor/defibrillators and automated external defibrillators (AEDs) used to provide cardioversion therapy to patients are being investigated by the Food and Drug Administration following reports that the devices designed to deliver 200 J (joules) were ineffective during use.
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.
A prescription brand of hypoallergenic dry powder formula, Neocate manufactured by Nutricia, is being recalled because of a blending error that has resulted in the product having lower levels of protein than declared on the label, according to the Food and Drug Administration (FDA).
The Food and Drug Administration (FDA) is notifying hemotology-oncology providers of an ongoing review of safety issues with Exjade (deferasirox), an oral medication used to treat patients aged 2 and older with chronic anemia and iron overload as a result of receiving blood transfusions. According to the early communication, new safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are older than 60 years of age and who have myelodysplastic syndrome (MDS), a potentially fatal condition that can require frequent blood transmissions.
The Food and Drug Administration (FDA) is reminding the public to check their personal supply of long-acting insulin Levemir made by Novo Nordisk Inc., because less than 2 percent of the stolen vials have been recovered and are likely still being distributed. Evidence suggests that the stolen insulin was not stored and handled properly and may be dangerous to those who use it. The FDA has received several reports of patients who suffered an adverse events due to poor control of glucose levels after using a vial from one of the stolen lots.
The Food and Drug Administration (FDA) is urging health care professionals to always recheck their dosing calculations prior to administering Arginine Hydrochloride Injections and to be aware that several unlabeled adverse events may be associated with the use of the drug, according to the Postmarket Reviews section of the Volume 2, Number 2 2, 2009 issue of its quarterly online newsletter, Drug Safety News (DSN).
The Food and Drug Administration (FDA) has issued a recall on Fun Express, Inc. brand water-based face paints due to adverse event reports of skin reactions in children exposed to various colors of the face paint. The “Face Paint” was labeled and distributed by Oriental Trading Co., and all exposures happened at the same day and at the same organized event. Adverse events reports included rashes, itchiness, burning sensation and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products tested by an FDA laboratory.
The paints are designed to be used on the face or body area using fingertips or brushes to make a desired design. The recall includes blue, purple, red, orange, black and green face paints. The FDA advises consumers to stop the use of these products and discard them or return them to the retailer.
Individuals with questions or who have experienced any adverse reaction from face paints should contact the FDA as well as state and local health authorities. To contact the FDA’s MedWatch Adverse Event Reporting system go online at http://www.fda.gov/medwatch/report.htm or call 800-FDA-1088.
Source: FDA
The Food and Drug Administration (FDA), as part of an ongoing safety review, has notified manufacturers of licensed botulinum toxin products – also known as Botox and Botox Cosmetic and Myobloc – of the need to strengthen warnings in product labeling and add a boxed warning of the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.
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