Weekly FDA Enforcement Report For Drugs And Biologics 5/7/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 7, 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: Hospira recalled Lidocaine HCl Injection because a customer complained of particulates in the vial. Medisca recalled Human Chorionic Gonadotropin due to a labeling error. Deseo Rebajar recalled Adipotrim XT because of undeclared Fluoxetine. B. Braun Medical recalled several Class I products including Cefoxitin for Injection and Dextrose Injection, Ceftriaxone for Injection, and Dextrose Injection, 6.9% FreAmine HBC, and Hyperlyte CR due to visible particulates.

Classification II Recall

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

• Biologics: OneBlood Inc. recalled Red Blood Cells and Cryoprecipitated AHF. Avera McKennan Hospital & University Health Center recalled Plasma and Red Blood Cells Leukocytes Reduced. Mid-America Transplant Services recalled Human Corneas because of donor eligibility issues.
• Drugs: Teva Pharmaceuticals USA recalled Glyburide and Metformin Hydrochloride Tablets, Indomethacin Capsules, and Methyldopa Tablets because laboratory testing was not followed in accordance with GMP requirements. John W Hollis Inc. recalled Phosphatidylcholine Solution and Polidocanol 3% Solution because of an incorrect expiration date and particulate in the solution. Caraco Pharmaceutical Laboratories, Ltd. recalled Venlafaxine Hydrochloride Extended-Release Tablets because the product did not meet the drug release dissolution specifications. AbbVie Inc. recalled Lupron Depot because of a defective delivery system.

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 recalled 111 units of Red Blood Cells Leukocytes Reduced, Cryoprecipitated AHF, Platelet, Pheresis, Leukocytes Reduced, Plasma, and Red Blood Cells because of unacceptable temperatures during shipment. The University of Miami, Miller School of Medicine Tissue Bank recalled 99 Bone Allografts because of mislabeling.
• Drugs: Apotex recalled Risperidone Oral Solution. Caraco Pharmaceutical Laboratories recalled Children's Cetirizine Hydrochloride Chewable Tablets. Aaron Industries recalled Maximum Strength/Non-Drowsy Tussin DM due to the presence of Guaifenesin.