Getting the facts on FDA recalls
On behalf of Jacqueline A. Scott & Associates posted in medical malpractice on Wednesday, March 7, 2018.
Under federal law, the U.S. Food and Drug Administration is empowered to require private companies to issue recalls in the event a product is discovered to be defective or harmful to the public. Such recalls, according to the FDA, are issued under one of three different classifications. The severity of the product’s potential harm is classified in ascending order by three different levels. Each classification gives the Louisiana public a general idea of how defective and dangerous the product is.
To start with, products that are not likely to result in any serious health reaction are classified under a Class III recall. These products are recalled because they are in violation of manufacturing laws or FDA labeling requirements. For example, a can of soup may not be properly labeled, or may not have a labeling in English. Class III recalls may also be issued when a container possesses a minor physical defect.
Products that are subject to Class II recalls are at greater risk of producing health problems. Generally, these problems are of a temporary nature. Possible Class II recalls can include medical drugs that are used to treat disorders or ailments that do not threaten a person’s life. Recalled drugs may produce slight or non-permanent health side effects. Additionally, a Class II recalled product can be a serious health risk, but the threat is slight.
Recalled products under a Class I designation are the most dangerous, as their defects can result in serious health issues or even death. There are any number of scenarios that can make such products dangerous, like medical devices intended to sustain life that are discovered to be defective, a food label that fails to alert the user to dangerous allergens, drugs and medicines that are mislabeled, or toxins that are mixed in with food.
As Findlaw points out, not all FDA recalls apply to a person’s particular situation, so there should not be immediate alarm if individuals find their product was recalled. A person who has purchased a FDA recall should look at why the product was recalled. Some products only pose a threat to a narrow slice of the public. Some foods or medicines pose specific dangers to people with specific health conditions or if they are pregnant. However, anyone that believes the product could be dangerous is advised to stop consuming it. If the product does not perish after a period of time, the owner may consider keeping it in a safe place away from children or pets. In the event the product does produce adverse effects, keeping some of it may serve as evidence in future litigation.