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The continuing challenge of drug recalls: insights from a ten-year FDA data analysis

Seppe Ghijs (UGent) , Evelien Wynendaele (UGent) and Bart De Spiegeleer (UGent)
(2024) JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. 249.
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Abstract
In this study we analyzed drug recall data from the U.S. Food and Drug Administration (FDA) over the period 2012-2023. We identified trends in the number of recalls initiated annually and their underlying causes. On average, 330 drug recalls are initiated each year, showing an overall increasing trend. The average duration of a recall, from initiation to termination date, was 1.3 years and each recall involved on average 400 000 product units, implying considerable resource demands and consequences for all stakeholders. The most frequent cause of these recalls was found to be impurities and contaminants (37 %), followed by control (28 %) and labeling/ packaging (19 %) issues. Recalls of medicines causing serious health problems or death (class I), accounted for 14 % of the recall events. Continuous evaluation of recalls is expected to reduce their number, mitigate their impact on the healthcare system and improve drug safety.
Keywords
PRODUCT RECALLS, Drug recalls, FDA, Impurities, Quality control, Healthcare impact, Quality defects

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MLA
Ghijs, Seppe, et al. “The Continuing Challenge of Drug Recalls:  Insights from a Ten-Year FDA Data Analysis.” JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 249, 2024, doi:10.1016/j.jpba.2024.116349.
APA
Ghijs, S., Wynendaele, E., & De Spiegeleer, B. (2024). The continuing challenge of drug recalls:  insights from a ten-year FDA data analysis. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 249. https://doi.org/10.1016/j.jpba.2024.116349
Chicago author-date
Ghijs, Seppe, Evelien Wynendaele, and Bart De Spiegeleer. 2024. “The Continuing Challenge of Drug Recalls:  Insights from a Ten-Year FDA Data Analysis.” JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 249. https://doi.org/10.1016/j.jpba.2024.116349.
Chicago author-date (all authors)
Ghijs, Seppe, Evelien Wynendaele, and Bart De Spiegeleer. 2024. “The Continuing Challenge of Drug Recalls:  Insights from a Ten-Year FDA Data Analysis.” JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 249. doi:10.1016/j.jpba.2024.116349.
Vancouver
1.
Ghijs S, Wynendaele E, De Spiegeleer B. The continuing challenge of drug recalls:  insights from a ten-year FDA data analysis. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. 2024;249.
IEEE
[1]
S. Ghijs, E. Wynendaele, and B. De Spiegeleer, “The continuing challenge of drug recalls:  insights from a ten-year FDA data analysis,” JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 249, 2024.
@article{01J535Q2RHXNZ8PNK4GVMAEZ0D,
  abstract     = {{In this study we analyzed drug recall data from the U.S. Food and Drug Administration (FDA) over the period 2012-2023. We identified trends in the number of recalls initiated annually and their underlying causes. On average, 330 drug recalls are initiated each year, showing an overall increasing trend. The average duration of a recall, from initiation to termination date, was 1.3 years and each recall involved on average 400 000 product units, implying considerable resource demands and consequences for all stakeholders. The most frequent cause of these recalls was found to be impurities and contaminants (37 %), followed by control (28 %) and labeling/ packaging (19 %) issues. Recalls of medicines causing serious health problems or death (class I), accounted for 14 % of the recall events. Continuous evaluation of recalls is expected to reduce their number, mitigate their impact on the healthcare system and improve drug safety.}},
  articleno    = {{116349}},
  author       = {{Ghijs, Seppe and Wynendaele, Evelien and De Spiegeleer, Bart}},
  issn         = {{0731-7085}},
  journal      = {{JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS}},
  keywords     = {{PRODUCT RECALLS,Drug recalls,FDA,Impurities,Quality control,Healthcare impact,Quality defects}},
  language     = {{eng}},
  pages        = {{10}},
  title        = {{The continuing challenge of drug recalls:  insights from a ten-year FDA data analysis}},
  url          = {{http://doi.org/10.1016/j.jpba.2024.116349}},
  volume       = {{249}},
  year         = {{2024}},
}
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