Open Access Thesis
Master of Science (MS)
Irwin Martin, Ph.D., Chair
Jean Rowan, M.D., M.S.
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.
Gollamudi, Vimala Devi, "Review of drug and biologics recalls: 2009 through 2019" (2020). Master's Theses and Doctoral Dissertations. 1049.