Drug Product Recalls In 2009: Categorized By Problem Area
This article was originally published in The Gold Sheet
Executive Summary
The information on drug product recalls in the following pages has been collected and categorized by "The Gold Sheet" from FDA "Enforcement Reports" issued during calendar year 2009.
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1999-2009 RECALLS BY PROBLEM AREA AND DOSE FORM
The following tables list the number of drug recalls for last year and the previous decade by problem area and dose form. The problem area abbreviations are spelled out in the headnote to the box of "Drug Product Recalls In 2009: Categorized By Problem Area". The dosage form abbreviations below stand for: oral solid; injectable; oral liquid; topical; ophthalmic; active pharmaceutical ingredient; inhalable; nasal spray; suppository; otic; transdermal; and toothpaste and mouthwash.
2009 DRUG RECALL DATA ANALYZED BY DOSAGE FORM
The following is an analysis by dosage form of the data on drug recalls included in FDA "Enforcement Reports" during 2009. The chart includes the number of products recalled for each dosage form by market type (Rx vs. OTC), problem area and recall class. [EDITOR'S NOTE: See the head note of "Drug Product Recalls In 2009: Categorized By Problem Area" for more information on the recall data and categories.]
June Drug Product Recalls
June drug recalls feature massive Class II recall by Shreveport, La., repackager Advantage Dose due to cGMP nonconformance, comparable in scale and scope to Actavis Totowa, KV Pharmaceutical, Leiner Health Products recalls of recent years.