FDA announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced
Vi-Jon, Inc. issued a voluntary nationwide consumer product recall of a single lot of 28 fluid ounce bottles of Alpine Xtreme Evergreen Forest Body Wash after determining the presence of a bacteria, Enterobacter gergoviae, in some of the product samples tested. The company became aware of this after
FDA investigators and U.S. Marshals seized dozens of products from Shelhigh, Inc., Union, N.J., after finding short cuts in their manufacturing processes that may compromise the sterility, safety and effectiveness of their products.The products include pediatric heart valves and conduits (tube-like
The U.S. Food and Drug Administration (FDA) is alerting consumers to possible serious health risks from eating olives that may be contaminated with a deadly bacterium, Clostridium botulinum. C. botulinum can cause botulism, a potentially fatal illness. The olives are made by Charlie Brown di Rutigli
Johnson & Johnson recalled a recently launched Listerine plaque-detecting rinse marketed towards children after testing revealed contamination by microorganisms.All 4 million bottles of Glacier Mint and Bubble Blast flavors of Listerine Agent Cool Blue plaque-detecting rinse have been recalled. The
FDA has removed two of the three previously approved indications for the antibiotic Ketek (telithromycin). This drug is no longer indicated for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. FDA deleted the two indications because the benefits of using the drug in
The Food and Drug Administration has told Novartis Pharmaceuticals Corporation that it wants it to suspend marketing of Zelnorm, used to treat irritable bowel syndrome. The agency said it requested the voluntary action based on recent findings of an increased risk of serious heart problems associate
HoMedics® received complaints of user burns and fires to bedding, clothing and houses that were started by the heating pads. The FDA learned about these complaints during an FDA inspection of HoMedics®. The inspection also revealed quality system deficiencies related to design controls, complaint
From MedWatch – The FDA Safety Information and Adverse Event Reporting ProgramBarodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Amino
Florida Gov. Charlie Crist requested a $5,000,000 settlement for the parents of Martin Anderson, a 14-year-old who died at a Panama City boot camp last year, allegedly due to injuries from the boot camp’s guards. The settlement needs to be approved by the state legislature and came shortly after inc
Pharmaceutical giant Merck & Co. was ordered to pay $47.5 million in damages after a New Jersey jury decided that the company’s Vioxx medication was responsible for an Idaho man’s heart attack. The jury awarded $20 million in compensatory damages to Frederick Humeston and his wife and then tacked on
FDA Warns Consumers Not to Drink “Jermuk” Brand Mineral Water Due to possible Arsenic ContaminationThe US Food and Drug Administrationis warning consumers not to drink certain brands of mineral water imported from Armenia due to the risk of exposure to arsenic, a toxic substance and known cause of c
