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Table. Characteristics of FDA Class I Drug Recalls, 2004-2011
Table. Characteristics of FDA Class I Drug Recalls, 2004-2011
1.
US Food and Drug Administration.  Recalls, Market Withdrawals & Safety Alerts. http://www.fda.gov/Safety/Recalls/ucm289770.htm?source=govdelivery/. Accessed February 14, 2012
2.
US Food and Drug Administration.  Enforcement Reports. http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. Accessed August 2, 2011
3.
US Food and Drug Administration.  Background and definitions. http://www.fda.gov/Safety/Recalls/ucm165546.htm. Accessed August 3, 2011
4.
US Food and Drug Administration.  Archive for Recalls: Market Withdrawals & Safety Alerts. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm. Accessed August 2, 2011
5.
US Food and Drug Administration.  MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/Safety/MedWatch/default.htm. Accessed November 5, 2011
6.
US Food and Drug Administration.  Pathway to global product safety and quality. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf. Accessed February 21, 2012
7.
Pew Health Group.  After heparin: protecting consumers from the risks of substandard and counterfeit drugs. http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Reports/Pew_Heparin_Final_.pdf. Accessed September 8, 2011
8.
McMahon AW, Pratt RG, Hammad TA,  et al.  Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.  Pharmacoepidemiol Drug Saf. 2010;19(9):921-933PubMedArticle
Research Letters
July 23, 2012

The Epidemiology of Drug Recalls in the United States

Author Affiliations

Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Arch Intern Med. 2012;172(14):1110-1111. doi:10.1001/archinternmed.2012.2013

On January 31, 2012, Pfizer recalled nearly 1 million packs of birth control pills because of concerns that inert and active pills were miscounted and incorrectly ordered in their blister packs.1 This and other recent recalls highlight concerns about the potential clinical impact of defective and otherwise compromised drug products. However, little is known about the public health burden of drug recalls and whether health care providers are properly notified about clinically important recalls. We sought to quantify the frequency, cause, and extent of distribution of drug recalls in the United States and to evaluate the processes by which the US Food and Drug Administration (FDA) communicates clinically important recall information to health care providers.

Methods

We obtained data for all drug recalls in the United States between 2004 and 2011 from the publicly accessible FDA Enforcement Reports, which contain information on actions taken in relation to regulatory activities.2 For all Class I recalls—those with the greatest likelihood of causing patient harm3—we extracted the number of recalled lots and affected units, the geographic distribution of recalled units, the reason for the recall, and the presence of adverse events associated with the recall. To assess communication of clinically important recall information to health care providers, we cross-referenced Class I recalls with the FDA Archive for Recalls, Market Withdrawals & Safety Alerts (“Recall Alert System”), which the FDA uses to publish and notify subscribers of manufacturer-issued press releases about recalls of drugs and other FDA-regulated products.4 We also evaluated Class I recall communication through a second source—the FDA MedWatch Safety Alerts database (“MedWatch”)—which is sometimes used to communicate drug recall information.5

Results

Between 2004 and 2011, there were 1734 drug recall entries in the FDA Enforcement Reports; 91 were Class I (5%). The most common reasons for the recalls were contamination (n = 36; 40%) and wrong dose or release mechanism (n = 23; 25%) (Table). Most recalls affected multiple lots (n = 56; 62%) and more than 1000 units (n = 64; 70%), and 73 recalls involved units distributed nationwide or beyond (80%). Five recalls were initiated in response to adverse events (5%), ranging from lip swelling to death (eTable).

During this same period, the FDA issued 2912 Recall Alert System announcements, of which 166 were major human drug recall announcements for 126 unique products. Only 55 of these 126 were Class I recalls (47%). The FDA did not issue a Recall Alert System notice for 36 Class I recalls (40%); however, half (n = 18) were communicated through MedWatch, including all 5 recalls initiated in response to adverse events. Eighteen of 91 Class I recalls were not communicated through either system (20%).

Comment

Clinically important drug recalls occur nearly once per month in the United States and usually involve thousands of affected units distributed nationwide or beyond. Despite recent efforts by the FDA to address the drug recall burden,6 health care providers may be inadequately informed about clinically important recalls that threaten patient safety. The FDA did not issue any notifications through the Recall Alert System or MedWatch for one-fifth of Class I recalls. As the main mechanism of communicating recall information, the Recall Alert System should notify health care providers of all clinically important human medical product recalls.

Equally problematic, the Class I recalls that are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care (eg, veterinary drug recalls). It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.

In addition to improving communication of drug recall information, a system is needed to track the distribution of affected products throughout the supply chain to the patient level. Electronic tagging systems, such as radiofrequency identification technology, would enable pharmacies to quickly identify and notify affected individuals as soon as a recall is initiated, helping minimize exposure to potentially harmful products.7

Our analysis has several limitations. Only 5% of Enforcement Report entries for Class I recalls noted adverse events, which likely underestimates the frequency with which recalled products cause harm. The entry describing the 2008 heparin contamination did not mention adverse events; however, an FDA analysis found an excess of adverse events, including deaths, associated with contaminated heparin.8 Also, we did not evaluate other mechanisms by which health care professionals might receive drug recall information, such as “Dear Doctor” letters from manufacturers.

In conclusion, drug recalls in the United States are common and often involve serious defects that pose health risks to patients. Given the large number of affected units per recall and the widespread distribution of these units, solutions are needed to minimize patient harm when recalls occur. A comprehensive strategy would ensure that health care providers are properly notified about all clinically important drug recalls.

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Article Information

Correspondence: Dr Gagne, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (jgagne1@partners.org).

Published Online: June 4, 2012. doi:10.1001/archinternmed.2012.2013

Author Contributions: Dr Gagne had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Wang, Gagne, and Choudhry. Acquisition of data: Wang and Gagne. Analysis and interpretation of data: Wang, Gagne, and Choudhry. Drafting of the manuscript: Wang and Choudhry. Critical revision of the manuscript for important intellectual content: Wang, Gagne, and Choudhry. Statistical analysis: Wang and Gagne. Administrative, technical, and material support: Gagne. Study supervision: Gagne and Choudhry.

Financial Disclosure: None reported.

References
1.
US Food and Drug Administration.  Recalls, Market Withdrawals & Safety Alerts. http://www.fda.gov/Safety/Recalls/ucm289770.htm?source=govdelivery/. Accessed February 14, 2012
2.
US Food and Drug Administration.  Enforcement Reports. http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. Accessed August 2, 2011
3.
US Food and Drug Administration.  Background and definitions. http://www.fda.gov/Safety/Recalls/ucm165546.htm. Accessed August 3, 2011
4.
US Food and Drug Administration.  Archive for Recalls: Market Withdrawals & Safety Alerts. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm. Accessed August 2, 2011
5.
US Food and Drug Administration.  MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/Safety/MedWatch/default.htm. Accessed November 5, 2011
6.
US Food and Drug Administration.  Pathway to global product safety and quality. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf. Accessed February 21, 2012
7.
Pew Health Group.  After heparin: protecting consumers from the risks of substandard and counterfeit drugs. http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Reports/Pew_Heparin_Final_.pdf. Accessed September 8, 2011
8.
McMahon AW, Pratt RG, Hammad TA,  et al.  Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.  Pharmacoepidemiol Drug Saf. 2010;19(9):921-933PubMedArticle
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