Weekly FDA Enforcement Report For Drugs And Biologics

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 26, 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. Recalls can be viewed by Biologics or Drugs, and by Classification. 

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: No drugs recalled this week.

Classification II Recall

A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.

• Biologics: Blood Systems, Inc. of Scottsdale, AZ voluntarily recalled several biological products. Platelets Pheresis Leukocytes Reduced Irradiated did not meet the requirements for leukoreduced products. Blood and Blood Products for Reprocessing and Red Blood Cells Leukocytes Reduced were recalled due to a donor who was taking the drug Methotrexate. Platelets Pheresis Leukocytes Reduced tested positive for bacteria. The Blood Bank of San Bernardino and Riverside Counties recalled Platelets Pheresis Leukocytes Reduced, Red Blood Cells Leukocytes Reduced, and Plasma. Biomat USA, Inc. and DCI Biologicals Temple Terrace, LLC recalled Plasma. The Blood Centers of the Pacific - Irwin Center in San Francisco, CA recalled Platelets Pheresis Leukocytes Reduced due to improper production procedures.
• Drugs: No drugs recalled this week.

Classification III Recall

A Classification III recall signifies that the product is not likely to cause adverse health consequences.

• Biologics: Blood Systems recalled Platelets Pheresis Leukocytes Reduced due to uncontrolled storage temperatures. OneBlood, Inc. recalled Blood and Blood Products for Reprocessing due to an unsuitable donor. Belle Bonfils Memorial Blood Center recalled Red Blood Cells Leukocytes Reduced because not enough red cell preservative solution was added. The American Red Cross Blood Services from Birmingham, AL recalled Blood and Blood Products for Reprocessing due to an unsuitable donor.
• Drugs: No drugs recalled this week.

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.  Users can choose More Info for additional details and select Pending for recalls in the process of being classified. For more information, view the Enforcement Report Navigation and Definitions page.