Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency nquestion are taken off the shelves. The
charge of regulating the safety of drugs is the Foodpharmaceutical companies should also inform the FDA
and Drug Administration, is empowered by the USon the progress of the recalls until all the dangerous
government to review the application of adrugs are pulled out from the market.
pharmaceutical company to manufacture and releaseDuring the drug recall, the FDA assumes the role of a
to the market any new drug it develops. The FDAmonitoring agency and to ensure that the
also can issue a recall for any drugs that it deemspharmaceutical company is following all the necessary
dangerous for consumers. It also issues valuableprocedures in pulling out all the drugs which have
safety information so that the general public wouldbeen found to cause serious side effects. After all
know about which drug is unsafe to use.the drugs have been pulled out, the FDA then would
Sometime, however, the important safetyconduct an investigation on why the drug in question
information which is being issued regularly by thewas defective and to supervise the destruction of all
Food and Drug Administration can be a little bitthe recalled drugs or to make sure that the drugs
confusing. It is sometimes full of technical jargon thatare suitably reconditioned before they are
the consumer tends to get lost in the meaning of thereintroduced to the market.
words and paragraphs and some mistakes are madeThere are three recall categories and these are Class
because of this.I, Class II or Class III. In a Class I recall, the FDA
To put it more clearly, the FDA can order afinds that the drugs in question are causing serious
pharmaceutical company to recall what it deems as aside effects and a probable serious or fatal injury to
dangerous drug that is being distributed in thethe user exists and the drug has to be pulled out
market. The pharmaceutical company can also do itright away from the market. The Class II recall tells
voluntarily if it finds out that the drugs in question areof a probability of injury to the user although not
causing major side effects.necessarily fatal but still one that can cause
As soon as the recall is made by the FDA, thepermanent damage to the user. The Class III injury
pharmaceutical companies must take full responsibilitymeanwhile tells of a lesser, albeit, probable health
with regards to the pullout of these dangerous drugsrisks which is why the drug is being recalled.
and it also thoroughly checks that all the drugs in