Tuesday, March 25, 2014

Weekly FDA Enforcement Report For Drugs And Biologics

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for March 19, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action.
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
  • Biologics: No biologics recalled this week.
  • Drugs: CTV Best Group Inc., from Duluth, GA voluntarily recalled BEST Slim, a dietary supplement with 40 pills per bottle. The weight loss pill was marketed without FDA approval as an undeclared drug, sibutramine, was present. Specialty Medicine Compounding Pharmacy from Lafayette, South Lyon, MI recalled Dextrose Vial in Sterile Water due to non-sterility and mold in the product.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
  • Biologics: Blood Systems, Inc. from Scottsdale, AZ recalled several products including Red Blood Cells (Apheresis) Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced, and Platelets Pheresis Leukocytes Reduced Irradiated due to inappropriate testing and donor unsuitability. OneBlood, Inc. recalled plasma, platelets, and red blood cells. Mid-America Transplant Services recalled human corneas due to an unsuitable donor. 
  • Drugs: Actavis Elizabeth LLC from Elizabeth, NJ recalled Alprazolam 1 mg Tablets due to consumer complaints of significant tablet erosion. The recall was voluntary and nationwide.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
  • Biologics: Blood Systems, Inc. and OneBlood, Inc. also had a few Class III biologics recalls. One Lamda Inc. recalled Terasaki HLA Tissue Typing Trays due to false positive results.
  • Drugs: E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York recalled Triamcinolone Acetonide Cream USP due to a labeling error, which read 01% rather than 0.1%. Qualitest Pharmaceuticals recalled Carisoprodol Tablets due to impurities. Pinnacle Biologics, Inc. recalled Photofrin (porfimer sodium) for Injection due to faulty expiration dates.
About FDA Enforcement Reports
Users have several options in viewing the report. The Product view is set as default. Users can select Event View, Print-Friendly View, Pending, and Download CSV.  For more information, view the Enforcement Report Navigation and Definitions page.

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