Weekly FDA Enforcement Report For Drugs And Biologics 5/14/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 14, 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: Merck Sharpe & Dohme Corp. recalled Hepatitis B Vaccine (Recombinant) because one lot with a potential crack in the vial was distributed. The American National Red Cross ARC Blood Services N.E. Region recalled Red Blood Cells (Apheresis) Leukocytes Reduced because of compromised sterility. OneBlood Inc. recalled Red Blood Cells, Platelets, and Plasma because of an unsuitable donor. The American National Red Cross from Pomona, CA recalled Red Blood Cells and Plasma due to possible air contamination during collection.
• Drugs: Mangiacotti of Attleboro, MA voluntarily issued a nationwide recall of several varieties of Mangiacotti Sanitizer Spray, 15 mL spray bottle with the active ingredient Benzalkonium Chloride 0.1%. The recall was due to microbial contamination of serratia liquefaciens. Blu Pharmaceuticals Inc. recalled Metformin Hydrochloride Tablets because of a defective container. Wockhardt USA Inc. recalled Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications.

Classification III Recall

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

• Biologics: LifeServe Blood Center recalled Red Blood Cells Leukocytes Reduced because a donor’s arm inspection was not documented.  
• Drugs: Merck & Co Inc. recalled Liptruzet (ezetimibe and atorvastin) tablets in four strengths due to a defective container, in which some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. Boehringer Ingelheim Roxane Inc. recalled Azathioprine Tablets and Mercaptopurine Tablets because the product was given a 36 month expiration date instead of the filed 24 months.