Drugs that have been improperly sterilized, incorrectly labeled or those that have failed to meet national drug standards are all eligible to be recalled, by either the Food and Drug Administration (FDA) or the drug manufacturers themselves.
Class I recalls are the most serious, where a defective drug could reasonably cause serious or fatal health problems. Class II recalls may cause temporary or reversible health issues, but they can also cause secondary infections or complications with drug interactions.
Between 2004 and 2011, the FDA failed to report as much as 40 percent of all Class I drug recalls, which are the most dangerous. The FDA’s two systems of recall notification, MedWatch and the FDA’s Recall Alert System, have an overall failure rate of between 20 and 40 percent.
There is no federal law compelling pharmaceutical companies to disclose which drugs have been recalled, so consumers must rely on the FDA to provide that information to the public. Without these crucial facts, healthcare providers can continue prescribing defective or dangerous drugs.
Has My Drug Been Recalled?
Patients can find a list of Class I recalls for drugs and medical devices on the FDA website (www.fda.gov) under Recalls, Market Withdrawals and Safety Alerts. The website monitors Class II and Class III recalls in its weekly Enforcement Reports.
Contaminated or improperly labeled drugs can put patients at risk for serious infections and dangerous drug interactions. As a defender of public health, the FDA is responsible for making healthcare providers aware of all the risks.
At Proffitt & Cox LLP, we know how to how to defend the victims of drug injury. Our attorneys have years of experience in pharmaceutical litigation, and we know how to fight for you.
[Did You Know: Between 2004 and 2011, the FDA only announced 73 out of 91 Class I drug recalls.]
Proffitt & Cox, LLP – Columbia Injury Lawyer