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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Classes and Categories01:25

Drug Classes and Categories

Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

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Related Experiment Video

Updated: Jul 13, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

Association Between FDA Drug Recall Classification and Product-Related Characteristics.

Lantider K Bekele1, M Affan Badar2, Christopher J Kluse3

  • 1PhD Program in Technology Management (Quality Systems Specialization), Bailey College of Engineering and Technology, Indiana State University, Terre Haute, IN, 47809, USA. lbekele@sycamores.indstate.edu.

Therapeutic Innovation & Regulatory Science
|July 11, 2026
PubMed
Summary

FDA drug recalls are linked to specific causes and product types. Recall cause, such as contamination, strongly influences classification, highlighting patterns for regulatory oversight.

Keywords:
Chi-squareDrug recallsPharmaceutical qualityRecall causesRecall severity

Related Experiment Videos

Last Updated: Jul 13, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Public Health

Background:

  • The U.S. Food and Drug Administration (FDA) classifies drug recalls into three classes (I-III) based on the potential health risk.
  • Understanding factors associated with different recall classifications is crucial for effective regulatory action and public safety.

Purpose of the Study:

  • To investigate the associations between FDA drug recall classifications (Class I-III) and specific product-related characteristics.
  • To identify patterns in drug recalls that may inform regulatory surveillance and pharmaceutical quality management.

Main Methods:

  • A secondary analysis was performed on 13,248 FDA drug recalls from 2015 to 2024.
  • Data extracted included recall classification, cause, dosage form, therapeutic category, and geographic origin.
  • Statistical tests (Pearson's chi-square, Cramér's V) were used to assess associations and their magnitudes.

Main Results:

  • Significant associations were found between recall classification and recall cause, therapeutic category, dosage form, and geographic origin.
  • Recall cause demonstrated the strongest association (Cramér's V = 0.550), followed by therapeutic category (0.387) and dosage form (0.339).
  • Class I recalls were frequently linked to microbial contamination, adulteration, and unapproved drug status, with injectables and oral liquids disproportionately affected.

Conclusions:

  • Drug recall classification is significantly associated with product characteristics, especially the recall cause.
  • These findings reveal patterns in recall data that can guide risk-based regulatory surveillance.
  • The study highlights the need for robust pharmaceutical quality management, interpreting findings as patterns within recalled products, not comparative risk measures.