Weekly FDA Enforcement Report for Drugs And Biologics
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 5, 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. Users can view the recalls by Biologics or Drugs and by Classification, the danger level.
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
- Biologics: No classification I biologics were recalled this week.
- Drugs: Cubist Pharmaceuticals, Inc. of Lexington, MA recalled Cubicin (daptomycin), 500 mg lyophilized powder in 10 mL single-use vials, available by prescription only, due to glass particulates in the vials. Recalls for the same product were issued in recent weeks and the FDA issued a notification about the same problem last year. Hospira Inc. of Lake Forest, IL recalled Aminosyn II, 10%, Sulfite-Free Amino Acid Injection in a 500 mL container, for prescription only, due to particulates in the product.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: Several classification II biologics were recalled this week from various blood centers around the country. Blood Systems, Inc. voluntarily issued six recalls including Red Blood Cells Leukocytes Reduced and Platelets Pheresis Leukocytes Reduced. Reasons included possible West Nile virus contamination and not meeting the minimum volume. The Blood Bank of San Bernardino and Riverside Counties recalled Platelets Pheresis Leukocytes Reduced and Red Blood Cells due to unverified white blood cell count and lack of sterility.
- Drugs: Novartis Consumer Health issued a nationwide recall and recalls to Mexico, Russia, Korea, Panama, China, and Canada for several Theraflu and NeoCitran products due to the presence of foreign substances. Aidapak Services, LLC recalled many over-the-counter drugs like Omega-3 and Coenzyme Q10 due to labeling mix-ups. The company also recalled several prescription-only drugs.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: Blood Systems, Inc. also had a few classification III red blood cell recalls due to unacceptable storage temperatures. The University of Miami Miller Tissue Bank voluntarily recalled human bone allograft tissue due to donor eligibility; non-adherence to FDA approved procedures to prevent communicable diseases. Greer Laboratories Inc. of Lenoir, NC initiated a recall for Sterile Diluent for Allergenic Extracts, 10% Glycerin w/v, 9 mL vial packaged in 25-count vials per carton, available by prescription only. The recall is nationwide due to sterility issues.
- Drugs: Pfizer Inc. recalled Zithromax for impurities. Teva Pharmaceuticals recalled Fluconazole Oral Suspension because of failed stability testing. Mutual Pharmaceutical Company, Inc. recalled Fenofibric Acid immediate release tablets due to incorrect medical advice on the label. G & W Laboratories Inc. issued a nationwide voluntary recall for Fluocinolone Acetonide Cream USP 0.025%.
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. Information can be sorted 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. For more information, view the Enforcement Report Navigation and Definitions page.