In a new report released by Congress’s investigative branch, the Government Accountability Office (GAO) the U.S. government is criticized for its oversight of nursing homes across the nation. According to the report published in The New York Times, nursing homes and long-term care facilities that ar
The FDA received information showing that 24 apparently related websites operated outside the US may be involved in the distribution of counterfeit prescription drugs. On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120mg Capsules, a drug used to help obes
A 2-year-old girl in Miami was left sweltering in a car on the hottest day of the year so far, while her guardians shopped at a Miami plaza.Police received a call from witnesses that said they had spotted the 2-year-old girl sweating profusely and hysterically going back and forth between the seats
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
