A pharmaceutical company may start a recall of a drug that it has manufactured, or sometimes the federal Food and Drug Administration will start the recall process. This is based on the mission of the FDA to make sure that consumers receive safe food, pharmaceuticals, medical devices, and related products. While the FDA does not test drugs, it reviews the results of tests conducted by the manufacturer of a drug before the drug reaches the market. Manufacturers are required to test their drugs on animals and humans and then send the results to the FDA for examination. The Center for Drug Evaluation and Research will approve a drug for general release only if the tests show that it is adequately safe and effective.
However, a manufacturer has a continuing duty after a product is released to monitor it for any issues. It must look into problems that consumers report or that it discovers through its ongoing research. The manufacturer must report any issues to the FDA, while consumers and medical professionals also can report issues through the MedWatch program. This may result in further tests on the drug or in a recall if the problem is serious.
The FDA or the manufacturer will start the recall process if they decide that a drug should not be available to consumers because it poses too great a risk. Most commonly, a recall will occur if the manufacturer or the FDA believes that the drug causes serious side effects that were not previously known. A recall also can occur if reports suggest that consumers are using the drug in an unauthorized way that poses a serious risk of harm. In other situations, the FDA may ask or order the manufacturer to issue a recall if it believes that a safer alternative to a pharmaceutical exists. Sometimes a recall will affect only a certain batch of a drug that has a problem, rather than the entire line.
Recalls are grouped into certain categories, of which the most dangerous is Class I. This category of recall means that using the drug creates a reasonable probability of serious harm or death. Meanwhile, a Class II recall means that using the drug may carry a risk of temporary health issues or a very small risk of serious harm. A Class III recall means that the drug is defective but probably will not actually harm consumers. A manufacturer also may issue a type of recall known as a market withdrawal when a problem arises that does not reach a level that concerns the FDA.
If the manufacturer starts the recall process, it will need to inform the FDA and monitor the process to make sure that it unfolds properly. The manufacturer may need to submit reports to the FDA on the status of the recall. Manufacturers almost always comply with any requests by the FDA to recall a product. The FDA can pursue a court order to seize the drug if the manufacturer does not comply.
You can get information about recalls of pharmaceuticals and medical devices by consulting the FDA website. The main list covers Class I recalls, but Class II and Class III recalls will appear in the Enforcement Reports on the website. In addition, the manufacturer of the drug must notify any entities to which it directly sells the drug. The manufacturer will inform a store or distributor about the recall, ask it to stop selling the drug, and tell it how to handle any supplies of the drug. The store or distributor also may need to notify its customers of the recall. Very serious problems associated with a defective drug tend to attract the attention of the media, so the general public may be aware already.
