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Understanding drug recall classifications

Residents of The Woodlands rely on various forms of prescription and over-the-counter medications for relief from all manner of health concerns. Very rarely may they view such drugs as presenting the potential for harm. Yet every year, prescription drugs are recalled by the U.S. Food and Drug Administration. In fact, the number of drug recalls issued annually has been increasing in recent years. According to information shared by the Regulatory Affairs Professionals Society, the average number of Class I, II and III drug recalls in the U.S. from 2009-2013 was 42.4, 373.6 and 99.6, respectively. Those numbers were a significant increase from the averages of 9.8, 100.2 and 62.8 seen for the same classes from 2004-2008. 

Most may have heard of the different classifications of drug recalls in the past, yet are unfamiliar with the details defining them. The FDA lists the criteria for the different categories of product recalls as follows: 

  • Class I: Exposure to the recalled product carries with the reasonable probability of causing serious adverse health consequences or death
  • Class II: Exposure to the recalled product may have a remote potential of causing serious adverse health consequences, and a greater probability of causing temporary or medically reversible health issues
  • Class III: Exposure to the recalled product is unlikely to cause adverse health consequences 

Even in cases of Class III recalls, consumers should treat all drug recalls seriously. They should contact the manufacturer to get details on how to dispose of the drugs, and to see if they are entitled to a refund of the medication's purchase price. It should also be remembered that simply having a recall in place does not absolve a manufacturer of liability should a medication cause harm. 

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