What's New

• Steam Dietary Supplement 
  [UPDATED] Nationwide recall expanded, new lot added due to undeclared drug ingredient. Posted 08/24/2009
• Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review 
  FDA is reviewing reports of serious liver injury, including liver failure. Posted 08/24/2009
• Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] 
  Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection. Posted 08/24/2009
• Ibuprofen (Unapproved) topical drug products 
  The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. [08/21/2009]
• Hospira, Inc. Device Recall 
  Potential risks from Hopsira, Inc. devices power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. [Posted 08/17/2009]
• Dextroamphetamine, Amphetamine 20mg Tablets 
  Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Posted 08/14/2009
• CellCept (mycophenolate mofetil) August 2009 
  Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. Posted 08/14/2000
• GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology 
  Possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. Posted 08/13/2009
• Nuby Gel Filled, Cottontails, and Playschool Teethers 
  [UPDATE] Recall classified as Class 1. Posted 08/13/2009
• July 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 08/12/2009
• Alaris System (Cardinal Health) 
  Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death. Posted 08/05/2009
• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 
  FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. Posted 08/04/2009
• FDA Patient Safety News Video Broadcasts 
  August 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 08/04/2009
• Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) 
  [UPDATED] FDA announced changes to the established drug names to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and...
• POWERSAIL Coronary Dilatation Catheters 
  Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction. Posted 07/30/2009
• Colchicine (marketed as Colcrys) 
  Two previously uncharacterized safety concerns associated with the use of colchicine. Posted 07/30/2009
• Body Building Products (Marketed as Containing Steroids or Steroid-like Substances) 
  Products are unapproved drugs and associated with serious risks of liver injury, stroke. Posted 07/28/2009