Weekly FDA Enforcement Report For Drugs And Biologics 7/30/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for July 30, 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. View the recalls 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 Class I biologics recalled this week.
• Drugs: Shamrock Medical Solutions Group had several recalls this week due to labeling mix-ups. The company from Lewis Center, OH recalled Taztia XT (Diltiazem HCl), Oxycodone HCl Oral Concentrate, Metformin, Pramipexole Dihydrochloride, Sulfamethoxazole and Trimethoprim, and Docusate Calcium.

Classification II Recall

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

• Biologics: Coastal Bend Blood Center recalled Red Blood Cells Leukocytes Reduced Irradiated due to a donor who travelled to an area known for malaria. Bergen Community Regional Blood Center recalled Platelets Pheresis Leukocytes Reduced due to unacceptable specifications. The Community Blood Center of the Carolinas recalled Platelets Pheresis Leukocytes Reduced because of unacceptable quality control. Michigan Blood recalled Platelets Pheresis Leukocytes Reduced because the donor travelled to an area known for malaria.
• Drugs: Franck's Lab dba Trinity Care Solutions from Ocala, FL recalled numerous products because a recent FDA inspection showed concerns with quality control and lack of assurance of sterility. Recalls include Levofloxacin, Vancomycin, Pfizerpen (penicillin G), and 27 others.

In May 2014, the FDA inspected Franck’s and issued a report. The FDA was concerned that recent remodeling affected the airflow in the clean room. A ground level vent was not easily cleaned and could be a source of viable and non-viable particles. Ceiling tiles were made of porous materials not suitable for a clean room. Inspectors also noticed flaking paint and rust that technicians could rub against and transfer during drug compounding.

Classification III Recall

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

• Biologics: The American National Red Cross SW Region and Penrose-St. Francis Health Services Blood Bank recalled Red Blood Cells Leukocytes Reduced. Bio-Rad Medical Diagnostics recalled Reagent Red Blood Cells due to misbranding.
• Drugs: X-Gen Pharmaceuticals recalled Clonidine HCl Injection due to labeling on declared strength. Sandoz recalled Orphenadrine Citrate Extended Release Tablets because of failed stability testing.