Understanding US Food and Drug Administration Recalls

The Food and Drug Administration, the agency n charge of regulating the safety of drugs is the Food and Drug Administration, is empowered by the US government to review the application of a pharmaceutical company to manufacture and release to the market any new drug it develops. The FDA also can issue a recall for any drugs that it deems dangerous for consumers. It also issues valuable safety information so that the general public would know about which drug is unsafe to use.

Sometime, however, the important safety information which is being issued regularly by the Food and Drug Administration can be a little bit confusing. It is sometimes full of technical jargon that the consumer tends to get lost in the meaning of the words and paragraphs and some mistakes are made because of this.

To put it more clearly, the FDA can order a pharmaceutical company to recall what it deems as a dangerous drug that is being distributed in the market. The pharmaceutical company can also do it voluntarily if it finds out that the drugs in question are causing major side effects.

As soon as the recall is made by the FDA, the pharmaceutical companies must take full responsibility with regards to the pullout of these dangerous drugs and it also thoroughly checks that all the drugs in question are taken off the shelves. The pharmaceutical companies should also inform the FDA on the progress of the recalls until all the dangerous drugs are pulled out from the market.

During the drug recall, the FDA assumes the role of a monitoring agency and to ensure that the pharmaceutical company is following all the necessary procedures in pulling out all the drugs which have been found to cause serious side effects. After all the drugs have been pulled out, the FDA then would conduct an investigation on why the drug in question was defective and to supervise the destruction of all the recalled drugs or to make sure that the drugs are suitably reconditioned before they are reintroduced to the market.

There are three recall categories and these are Class I, Class II or Class III. In a Class I recall, the FDA finds that the drugs in question are causing serious side effects and a probable serious or fatal injury to the user exists and the drug has to be pulled out right away from the market. The Class II recall tells of a probability of injury to the user although not necessarily fatal but still one that can cause permanent damage to the user. The Class III injury meanwhile tells of a lesser, albeit, probable health risks which is why the drug is being recalled.