Review of drug and biologics recalls: 2009 through 2019

<p>This study analyzed drugs and biologics recalls for the period of 2009 and 2019. The data used in the study was generated from Food and Drug Administration records. A total of 466 drugs and 84 biologics were recalled during the 11-year period. The common causes of drug product recalls included contamination, defective products, and mislabeling. Defective product, mislabeling, and defective packaging were observed to be the common causes of recall for biologics. Injectables have the highest percentage of recalls in drug products, and blood and blood products had the highest percentage of recalls in biologics. Controlling the contamination of injectable and also minimizing mislabeling, defective packaging and defective product of blood and blood products could help in providing safer drugs and biologics to the public.</p>

Name thesis:degree_name

Master of Science (MS)

Level thesis:degree_level

Open Access Thesis

Discipline thesis:degree_discipline

Health Sciences

Year dc:date.available

2020

Author dc:creator

• Gollamudi, Vimala Devi

Contributors dc:contributor

• Irwin Martin, Ph.D., Chair
• Jean Rowan, M.D., M.S.

• Biologics
• Drugs
• Food and Drug Administration
• Recalls
• Chemicals and Drugs

Repository record dc:identifier

https://commons.emich.edu/theses/1049

OAI identifier oai:identifier

oai:commons.emich.edu:theses-2425