Weekly FDA Enforcement Report For Drugs And Biologics 6/25/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 25, 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: No Class I drugs recalled this week.

Classification II Recall

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

• Biologics: The Blood Alliance from Jacksonville, FL recalled Red Blood Cells because they were not manufactured in accordance with acceptable product specifications. The Central California Blood Center recalled Plasma and Red Blood Cells due to a donor at risk for a variant of Creutzfeldt-Jakob disease (v-CJD). OneBlood recalled Red Blood Cells, Plasma, and Platelets. Blood Systems recalled Platelets, Plasma, and Red Blood Cells. Blood Centers of the Pacific - Irwin Center recalled Platelets and Plasma. Saving Sight recalled Human Corneas due to an expired viewing chamber.
• Drugs: John W. Hollis from Nashville, TN recalled 19 products including Polidocanol 0.5% Solution for Injection, Liver Derivative Complex for Injection, and Testosterone Cypionate for Injection due to lack of sterility concerns. Thorne Research from Sandpoint, ID recalled Captomer 100 and 250 mg due to marketing without NDA/ANDA approval as the product contains Dimercaptosuccinic Acid (DMSA). Ferring Pharmaceuticals recalled TEV-TROPIN [somatropin (rDNA origin) for injection] because the product may contain silicone oil due to a leaking line during the freeze-drying process. Actavis recalled Vancomycin Hydrochloride Capsules due to subpotency.

Classification III Recall

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

• Biologics: Several blood centers issued Class III biologics recalls this week including Minnesota Lions Eye Bank, which recalled Human Corneas due to inappropriate corneal preservation media. The Gulf Coast Regional Blood Center recalled Red Blood Cells due to a donor with a history of polycythemia vera.
• Drugs: Novartis recalled Foradil Aerolizer (formoterol fumarate inhalation powder) due to failed content uniformity specifications.