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 January 29, 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 biologics recalled this week
- Drugs: Cubist Pharmaceuticals, Inc. from Lexington, KY has voluntarily recalled Cubicin (daptomycin for injection), 500 mg lyophilized powder in 10 mL single-use vials, available by prescription only. Cubicin is used to treat certain kinds of infections. The recall is due to the presence of glass particulates in the vials.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: LifeSouth Community Blood Centers, Inc. recalled Platelets Pheresis Leukocytes Reduced. Community Blood Center of Greater Kansas City recalled Red Blood Cells Leukocytes Reduced due to possible malaria contamination. Several other products from different sources have been recalled due to uncertainty about a donor’s suitability.
- Drugs: Novartis Consumer Health recalled several Theraflu and NeoCitran products due to the presence of foreign substances. Fresenius Kabi USA, LLC recalled Tranexamic Acid Injection due to particulate in the glass vial. Greenstone LLC recalled Sertraline HCL tablets due to incorrect labeling.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: OneBlood, Inc. recalled frozen plasma and Arc Blood Services recalled blood products.
- Drugs: Teva Pharmaceuticals USA, Inc. the distributor for Fluconazole Oral Suspension, recalled the 10 mg/mL, 35 ml bottle. Manufactured by Cipla, the product was recalled because it failed stability testing.
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.