title: Characteristics of FDA drug recalls: A 30-month analysis.
abstract: OBJECTIVE
  The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed.
  
  
  METHODS
  All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date.
  
  
  RESULTS
  A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication.
  
  
  CONCLUSIONS
  An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms.
authors: Walmart Pharmacy, Louisville, KY.
authors: Kelsey
authors: K
authors: Hall
authors: Mills Discount Pharmacy, Birmingham, AL.
authors: Tyler
authors: T
authors: Stewart
authors: Pharmaceutical Social and Administrative Sciences, McWhorter School of Pharmacy, Samford University, Birmingham, AL.
authors: Jongwha
authors: J
authors: Chang
authors: Pharmacy Practice, Center for Healthcare Innovation and Patient Outcomes Research, McWhorter School of Pharmacy, Samford University, Birmingham, AL. mkelly@samford.edu.
authors: Maisha Kelly
authors: MK
authors: Freeman
mesh_terms: D001688:Biological Products / Q000592:standards; D004340:Drug Contamination; D004348:Drug Labeling / Q000592:standards; D056736:Drug Recalls / Q000706:statistics & numerical data*; D006801:Humans; D004366:Nonprescription Drugs / Q000592:standards*; D055553:Prescription Drugs / Q000592:standards*; D012189:Retrospective Studies; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D004366:Nonprescription Drugs; D055553:Prescription Drugs