Weekly FDA Enforcement Report For Drugs And Biologics 7/9/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for July 9, 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: OneBlood recalled Red Blood Cells Leukocytes, Cryoprecipitated AHF, Platelets Pooled Leukocytes, Red Blood Cells, and Fresh Frozen Plasma due to an unsuitable donor. The Kentucky Blood Center recalled Red Blood Cells Leukocytes Reduced because of possible contamination with air during collection. The Blood Bank of Hawaii recalled Red Blood Cells Leukocytes and Platelets Pheresis Leukocytes due to a donor with possible Creutzfeldt-Jakob disease (vCJD) and a donor with an inadequate health history. Others with Class II recalls include the Lifesouth Community Blood Centers, Montgomery Region, the American National Red Cross, Penn Jersey Region, and the Central California Blood Center.
• Drugs: West-Ward Pharmaceutical recalled Isoniazid and Forest recalled Bystolic due to failed dissolution specifications. Baxter recalled Brevibloc due to agglomerating subvisible particles of iron oxide. Brookfield Prescription Center recalled Mometasone, Diphenhydramine, and HCG (Human Chorionic Gonadotropin) because they were compounded with an incorrect solvent. Caraco Pharmaceutical Laboratories recalled Venlafaxine Hydrochloride because it did not meet dissolution specifications.

Classification III Recall

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

• Biologics: LifeSource of Rosemont, IL recalled Red Blood Cells and Red Blood Cells Leukocytes Reduced due to a donor with polycythemia vera, a bone marrow disorder. Medic recalled Red Blood Cells Leukocytes Reduced because it failed to meet the minimum specification for red blood cell percent recovery. Upstate New York Transplant Services recalled Cryoprecipitated AHF because it was processed more than eight hours after collection. Cangene Plasma Resources recalled Source Plasma because of a donor with an incomplete medical history interview. The American National Red Cross recalled Platelets and Blood Products due to a donor who reported a post donation illness. The American National Red Cross SW Region recalled Blood Products due to an unsuitable donor.
• Drugs: No Class III drugs recalled this week.