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 according to the required current good manufacturing practice (CGMP) and many also lack required...
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 determining that some of the product had become cloudy in appearance. An investigation concerning...
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 devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after...
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 Rutigliano & Figli S.r.l, of Bari, Italy and are being recalled by the manufacturer. No illnesses have...
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 recall covers all lots sold or distributed since the product's launch last year.Consumers should...
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 these cases do not outweigh its risks. The one remaining FDA-approved indication is for the...
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 associated with use of the drug.But some doctors say there's nothing recent about the findings. In March...