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FDA prescription drug recalls protect Virginia patients

Virginians take prescription drugs with the goal of improving their health or easing an ongoing medical problem. They receive a prescription from a doctor specifically intended to improve an ailment and take the drug with the aim that it will help them. What Virginians likely do not count on, however, is that the drug prescribed and received could harm them instead. When it is determined that a drug is unsafe, a prescription drug recall will be issued, and such a recall may ultimately give rise to products liability lawsuits.

A product recall may be initiated by the drug company, by the request of the FDA or by order of the FDA based on the agency's statutory authority. There are three classes of recalls. The most serious type of recall, a Class I recall, is initiated when a reasonable probability exists that upon exposure to or use of a certain product, a person will experience serious adverse health consequences, or even death.

In a Class II recall, the product is recalled because exposure to or use of the dangerous product may cause medically reversible adverse consequences to a user's health. Additionally, Class II recalls are issued when there is a remote probability of serious adverse health effects after use of the product. A Class III recall may be issued when use of a particular product is not likely to cause adverse health consequences, but nonetheless it is deemed appropriate to recall the product.

The FDA acts and issues recalls to help protect patients from potentially dangerous drugs. Nevertheless, injuries and adverse consequences do occur. If a patient has suffered adverse health consequences after use of a prescription drug that has been recalled, they may wish to seek legal counsel to discuss their rights and options.

Source: FDA, "Safety: Background and Definitions", accessed Sept. 25, 2015

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