An Analysis of Class I Recalls: 1982–1996
Class I recalls possess the greatest degree of health hazard and are frequently conducted to the consumer or user level. This study analyzes all Class I recalls appearing in the Food and Drug Administration (FDA) Enforcement Reports from 1982–1996. Major causes of Class I recalls over the past 14 years include: drug quality and good manufacturing practices (GMP) violations, mislabeling, and adverse reactions. Class 1 recalls over this time period are analyzed by reason, brand versus generic company, dosage form (eg, injection, tablet), notification method, and further FDA enforcement action (eg, seizure, injunction, criminal prosecution). Trends are identified. Finally, the effectiveness of Class I recalls to the pharmacy level is assessed.
Key WordsClass I recalls Mislabeling Brand versus generic Dosage form Recall notification
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- 1.43 Federal Register 26202 (1978).Google Scholar
- 2.Fine SD. Recalls—Definition and exposition. Food Drug Cosmetic Law J. 1972;27:662–671.Google Scholar
- 3.Harper BM. Mandatory food and drug recalls. An analysis of a developing FDA enforcement tool. Food Drug Cosmetic Law J. 1981;35:669–687.Google Scholar
- 4.Rumore MM. The drug product recall system and the pharmacist: Are consumers protected? N. Y. State J. Health Syst Pharm. 1996;15(10):137–159.Google Scholar
- 5.FDA Enforcement Manual. Tab 600. Recalls and administrative injunction. Thompson Publications Group, Inc.; 1992:44.Google Scholar
- 6.FDA Regulatory Procedures Manual. Part 5, Ch. 5.00-20. Recall and emergency procedures.Google Scholar
- 7.Clevenger WL. Recalls. Food, Drug, Cosmetic Law J. 1972;27:332–343.Google Scholar
- 9.Labeling/packaging error recalls down 43% in 1996. The Pink Sheet. T&G 6–7, January 20, 1997.Google Scholar
- 10.FDA seeks labeling regulation changes, disclosure of clinical trials in preliminary legislative agenda. FDC Reports—The Pink Sheet. 59(11):3–4, March 17, 1997.Google Scholar
- 11.Gumbhir AK, Jamison ML. Assessing the effectiveness of drug recalls in pharmacies. Drug & Cosmetic Ind. 1975;117:40–43, 113.Google Scholar
- 12.U.S.P. Quality Review. The U.S.P. Convention. 8/96.Google Scholar