An example would be an over-the-counter medication that has contamination from a toxin. 22072021 The FDA has identified this as a Class I recall the most serious type of recall. Use of these devices may cause serious injuries or death. The Agency states that voluntary recall is an alternative to the removal of medical devices from the market in accordance with a court order initiated by the FDA. Class I recalls usually pertain to defective products that can cause serious health problems or death.
A Class I recall is the most urgent and serious of the three types of FDA recalls. An example would be an over-the-counter medication that has contamination from a toxin. 26072021 The FDA has identified this as a Class I recall the most serious type of recall. Users can filter Recalls at either the Event or Product level. Class I recalls are reserved for cases where the product is violative violates FDA regulations and the issue can have serious consequences or death to humans or animals.