What's New

• Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall 
  [UPDATED 11/06/2009] Recall classified as Class I. Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Posted 10/30/2009
• Stiff Nights - product contains undeclared drug ingredient 
  Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. Posted 11/05/2009
• Centurion Medical Products - Premie Pack and Meconium Pack - Recall 
  Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. Posted 11/04/2009
• Bodybuilding.com Brand Dietary Supplements - Sold on Internet 
  Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. Posted 11/03/2009
• Unomedical Manual Pulmonary Resuscitator - Recall 
  [UPDATED 11/03/2009] Recall classified as Class I
• FDA Patient Safety News Video Broadcasts 
  November 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 11/03/2009
• Byetta (exenatide) - Renal Failure 
  Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. Posted 11/02/2009
• Cordis CROSSOVER Sheath Introducer - Recall 
  Nationwide recall due to stretching or fracture of the sheath during use. Posted 10/30/2009
• Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall 
  Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. Posted 10/27/2009
• Peramivir IV 
  Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. Posted 10/24/2009, UPDATED 10/30/2009
• Rituxan (rituximab) - PML 
  Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist. Posted 10/23/2009
• Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall 
  [UPDATED 11/3/2009]recall expanded to include all lots of product
• September 2009 
  Monthly Safety Labeling Changes - Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, PPI/Medication Guide sections of drug Prescribing Information. Posted 10/19/2009
• Medical Device Power Cords Safety Investigation: Initial Communication 
  Reports of sparking, charring, and fires from device power cords. Posted 10/19/2009
• Tamiflu (oseltamivir) for Oral Suspension 
  [UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet.
• Unapproved Drugs: Enforcement Actions 
  FDA directed four companies to stop making and distributing 30 mg and 60 mg codeine sulfate tablets that lack the required FDA approval. Posted 10/16/2009
• Dexferrum (iron dextran injection) - Labeling Change 
  Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Posted 10/16/2009