InjuryBoard Dallas Archives

• Permanent Injunction against PharmaFab Inc., PFab LP prescription and otc drugs

  RLF Staff | April 26, 2007 1:01 PM | 0 Comments
  Category: FDA & Prescription Drugs

  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...

• Bacteria Contamination Scare Prompts Alpine Xtreme Evergreen Forest Body Wash Recall

  RLF Staff | April 23, 2007 9:46 AM | 0 Comments
  Category: Defective & Dangerous Products

  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 Seizes Products From Medical Device Manufacturer

  RLF Staff | April 18, 2007 6:56 AM | 0 Comments
  Category: Defective & Dangerous Products

  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...

• FDA Warns Consumers about Potentially Contaminated Olives

  RLF Staff | April 16, 2007 7:56 AM | 0 Comments
  Category: Defective & Dangerous Products

  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...

• Listerine Agent Cool Blue Recalled

  RLF Staff | April 12, 2007 6:13 AM | 0 Comments
  Category: Defective & Dangerous Products

  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...

• Ketek Lable and Usage Changes

  RLF Staff | April 05, 2007 8:38 AM | 0 Comments
  Category: Miscellaneous

  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...

• FDA RECALL - V.MAX Erectile Dysfunction (ED) supplement(2)

  RLF Staff | April 03, 2007 7:50 AM | 0 Comments
  Category: FDA & Prescription Drugs

  Barodon 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 Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may...

• FDA asks for Voluntary Recall of Zelnorn

  RLF Staff | April 02, 2007 9:23 AM | 0 Comments
  Category: Miscellaneous

  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...