According to recent data released by United States Food and Drug Administration (FDA), 2014 is shaping up to be the largest year of serious drug recalls in the past 10 years. A recent story from RAPS takes a look at public data from the FDA that shows record numbers of recalls made in the pharmaceutical industry this year.
FDA recalls are generally the result of contamination, consumer health and safety concerns, or an apparent need for further testing. The FDA classifies recalls based on the severity and risk to the consumer in three basic tiers.
- Class I: reasonable probability exists that the recalled product may cause sever adverse health effects or even death.
- Class II: the use of or exposure to the recalled product may cause temporary or reversible medical conditions or the risk of serious adverse medical complications is remote
- Class III: the product is unlikely to cause serious adverse health consequences for users
The FDA classifies every recall by a company into one of these tiers. Last year, the FDA saw 1,225 total recalls, up from 499 in 2012. This year, they have already accumulated 836 recalls. The data shows that an overwhelming majority of the recalls have been Class II. This year, 77% of all recalls are Class II.
The rise in recalls has been largely spurred by a 2012 crackdown on compounding pharmacies after over 60 people died as a result of a fungal meningitis outbreak. A large number of Class II recalls were related to such facilities that had possible microbial contamination.
Recalls may be the result of pharmaceutical negligence that can cause severe health issues. Lopez McHugh attorneys are experienced in handling litigation against companies who disregarded the safety of consumers. If you or a loved one suffered an injury as a result of taking an unsafe medication or using an unsafe device, you may be entitled to financial compensation. Contact a Lopez McHugh attorney today at (877) 737-8525.