News Feature | February 25, 2014

Weekly FDA Enforcement Report For Drugs And Biologics

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By Cyndi Root

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 19, 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.

Classification I Recall

A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.

  • Biologics: No biologics recalled this week.
  • Drugs: No 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: Life Technologies Corporation voluntarily issued a recall for Allset Plus and Invitrogen HLA Typing Assay due to false negative results. Inland Northwest Blood Center recalled Cryoprecipitated AHF and Frozen Plasma due to collection from a donor with a history of Hepatitis after age eleven. Several other blood centers issued Class II recalls this week.
  • Drugs: Watson Laboratories, Inc. from Davies, FL recalled Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg in a 60-count bottle for prescription only, due to split tablets in stability samples. Activis, Inc. recalled Relstar (triptorelin pamoate) Injectable Suspension due to a labeling error. Mylan Pharmaceuticals Inc. recalled Levothyroxine Sodium Tablets, USP, 200 mcg in a 100-count bottle, available by prescription due to subpotency during stability testing. Caraco Pharmaceutical Laboratories Ltd. recalled Oxcarbazepine Tablets, 300 mg in 100 tablet bottles due to broken tablets.

Classification III Recall

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

  • Biologics: Blood Centers of the Pacific - Irwin Center recalled Red Blood Cells Deglycerolized Leukocytes Reduced. Antigen Laboratories Inc. recalled Bermuda Grass Pollen Allergenic Extract due to subpotency. 
  • Drugs: Bracco Diagnostics Inc. issued a recall nationwide and to Puerto Rico for VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w) in a 450 mL bottle, available by prescription only. The recall was due to failed stability testing.

About FDA Enforcement Reports

Users have several options in viewing the report. The Product view is set as default. Users can select Event View, Print-Friendly View, Pending, and Download CSV. For more information, view the Enforcement Report Navigation and Definitions page.

Sources:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=02192014&lang=eng#biologics

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=02192014&lang=eng#drugs

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