FDA Recall Definitions Flashcards
According to the Official FDA website "Recalls are actions taken by a firm to remove a product from the market. They may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority." The urgency and severity of an FDA Recall is what determines the "class" of the recall. Very similar to the DEA Sch., the FDA recall class schedule uses "1" as the most dangerous. However, unlike the DEA's schedule, the FDA Class schedule only goes to "3". The severity of
Class I
Would be used in a case where there is a probability that, the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II
Would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequences is remote.
Class
III
May be used in a situation in which use of a violative product is NOT likely to cause adverse health consequences, but has violated some FDA regulation.
FDA Market Withdrawal
Is appropriate when a product has a minor violation that would not be subject to FDA legal action. The manufacturer must remove the product from distribution markets or correct the violation. An example from the FDA Official website says, “A product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.”
FDA Medical Device
Safety Alert
Used only for medical apparatus equipment. This is when a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.
