News Feature | January 27, 2014

Weekly FDA Drugs Enforcement Report

Source: Pharmaceutical Online

By Cyndi Root

The Food and Drug Administration (FDA) has released its Enforcement Report for January 22, 2014. The agency issues the weekly report as not all recalls are publicized in press releases or other notifications. Manufacturers issue recalls or the FDA initiates the recall. Interested parties can view the product, manufacturer, reason for the recall and classification:

  • Classification I recall: a reasonable probability of serious adverse health consequences or death
  • Classification II recall: may cause temporary or medically reversible adverse health consequences
  • Classification III recall: not likely to cause adverse health consequences

Classification I Drug Recalls

Hospira Inc. from Lake Forest, IL has voluntarily issued a nationwide recall of Aminosyn II, 10%, Sulfite-Free Amino Acid Injection in a 500 mL container, available by prescription only. The recall is due to the presence of particulates. A customer complained about a human hair visible in the injection port and primary container.

Classification II Drug Recalls

Aidapak Services, LLC of Vancouver, WA had many products recalled. Over-the-counter drugs included zinc, calcium, omega-3, co-enzyme Q-10, and multivitamins to name a few. Prescription drugs recalled include Pseudoephedrine, Guaifenesin, Galantamine HBr ER, Itraconazole, and Omeprazole/Sodium Bicarbonate, among others. All the recalls were due to labeling mix-ups. The Specialty Medicine Compounding Pharmacy from South Lyon, MI had numerous recalls due to lack of sterility, as products were produced under the same conditions as another product found to be non-sterile. Several other manufacturers had Classification II recalls.

Classification III Drug Recalls

Novartis Consumer Health issued voluntary recalls for several products due to impurities and degradants found during testing. Products are for cold, cough, flu, and sinus relief.  Pfizer Inc. from New York, NY voluntarily issued a recall nationwide and in Puerto Rico for Zithromax (azithromycin for injection). The product is in a 500 mg sterile vial, for prescription only. The drug failed inspection due to an azithromycin N-oxide degradant.

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.  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.