An Analysis of Class I Recalls: 1982–1996


Class I recalls possess the greatest degree of health hazard and are frequently conducted to the consumer or user level. This study analyzes all Class I recalls appearing in the Food and Drug Administration (FDA) Enforcement Reports from 1982–1996. Major causes of Class I recalls over the past 14 years include: drug quality and good manufacturing practices (GMP) violations, mislabeling, and adverse reactions. Class 1 recalls over this time period are analyzed by reason, brand versus generic company, dosage form (eg, injection, tablet), notification method, and further FDA enforcement action (eg, seizure, injunction, criminal prosecution). Trends are identified. Finally, the effectiveness of Class I recalls to the pharmacy level is assessed.

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Correspondence to Martha M. Rumore PharmD, JD, RAC, FAPhA.

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Rumore, M.M. An Analysis of Class I Recalls: 1982–1996. Ther Innov Regul Sci 32, 65–71 (1998).

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Key Words

  • Class I recalls
  • Mislabeling
  • Brand versus generic
  • Dosage form
  • Recall notification