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FDA Reports Surge in Drug Recalls in Recent Years

By Orlando Personal Injury Attorney on August 20, 2014

According to data recently made public by the US Food and Drug Administration (FDA), recalls of pharmaceutical drugs have surged in recent years, with 2014 shaping up to be the biggest recall year on record.

According to the FDA website, there are three tiers of recalls. These tiers include:

  • Class I Recalls –
    A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  • Class II Recalls –
    A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III Recalls –
    A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

(Note that “violative” is a word sometimes used to describe something that is not allowed by rules or laws.)

FDA Drug Recalls by Year and Classification

To illustrate the rise in FDA prescription drug recalls in recent years, please view the FDA chart below:

Year Total Recalls Class I Class II Class III
2014* 836* 101 640 95
2013 1,225 59 1,031 135
2012 499 29 381 89
2011 444 66 236 142
2010 246 35 135 76
2009 164 23 85 56
2008 203 18 128 57
2007 126 11 56 59
2006 116 1 109 6
2005 253 8 140 105
2004 166 11 68 87

*Year as of August 2014

As you can see, the increase is largely driven by a surge in Class II recalls. However, there has also been a marked increase in the far more dangerous and potentially lethal Class I recalls as well.

The FDA is not yet sure why there has been such an alarming increase in drug recalls in recent years. However, they did say that a recent agency crackdown on compounding pharmacies might be a contributing factor. In 2012, FDA investigators traced a massive outbreak of fungal meningitis to a compounding pharmacy in Massachusetts. Infections from tainted medication produced by the pharmacy killed 60 people and sickened hundreds more.

James O. Cunningham

Since 1977, personal injury lawyer James Cunningham has provided effective legal advocacy to people who are injured through the negligent actions of another person or entity throughout the Central Florida area. He fights to obtain recoveries for his clients’ physical and emotional pain and suffering and pursues his clients’ personal injury cases with a commitment to excellence and impeccable preparation.

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