Weekly FDA Biologics Enforcement Report
By Cyndi Root
The Food and Drug Administration (FDA) has released its Biological product Enforcement Report for January 22, 2014. The FDA oversees biological products such as blood, blood components, vaccines, cells, tissue, and recombinant proteins. Sources are human, animal, or biological derivatives. The FDA publicizes recalls in its weekly report, as not all recalls are announced by press release. Recalls are FDA issued or voluntarily issued by the manufacturer and can be viewed by classification:
- Class I recall: a reasonable probability of serious adverse health consequences or death.
- Class II recall: may cause temporary or medically reversible adverse health consequences
- Class III recall: not likely to cause adverse health consequences
Classification I Biologics Recall
The Musculoskeletal Transplant Foundation has voluntarily recalled the Cascade Autologous Platelet System because a yellow tube may have higher than normal endotoxin levels. The recall is nationwide plus Spain and Portugal. The University of Miami Miller School of Medicine Tissue Bank has voluntarily issued an alert to Florida and New York to recall its bone tissue allografts, which may be positive for Clostridium.
Classification II Biologics Recall
The Community Blood Center of the Ozarks has recalled Red Blood Cells Leukocytes and Blood Products for Reprocessing due to a donor who resided with someone with Hepatitis B. The New York Blood Center, Inc. recalled Cryoprecipitated AHF and Red Blood Cells (Apheresis) Leukocytes Reduced. The Indiana Blood Center recalled Red Blood Cells Leukocytes Reduced. Several other blood centers recalled biological products this week. Reasons included possible contaminations of Creutzfeldt-Jakob Disease, malaria, and aspirin.
Classification III Biologics Recall
The Central California Blood Center initiated a recall for Red Blood Cells Leukocytes. The American National Red Cross recalled Blood Products for Reprocessing due to the possibility of an unsuitable donor. The Mississippi Valley Regional Blood Center recalled Red Blood Cells Leukocytes Reduced due to it containing anti-Fya antibody. The Coffee Memorial Blood Center recalled Blood and Blood Products for Reprocessing because a donor’s suitability was not properly determined.
About FDA Enforcement Reports
For more information, view the Enforcement Report Navigation and Definitions page. 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. Sort information by Reason for Recall, Classification, Code, and Recalling Firm. Choose More Info for additional details and select Pending for recalls in the process of being classified.