Drugs that come onto the market must be safe for humans to take. Unfortunately, this isn't always the case and recalls are sometimes necessary. When a recall does occur, there are several things that are considered.
The first thing that is considered is how the recall came about. There are three possibilities for this. The first is that the recall was voluntarily issued from the manufacturer. The second is that the U.S. Food and Drug Administration recommended the recall. The final is that the FDA forced the recall.
Recalls are divided into classes based on the issue that is present. There are three classes and two other categories that might occur when drugs or other medical devices are recalled.
A class III recall is one that involves a drug that isn't likely to cause adverse issues to consumers.
A class II recall is one that involves a drug that might cause reversible or temporary problems. The probability of these issues is considered remote.
A class I recall is the most serious. In this case, use of the drug might cause death or serious harm. These risks are considered highly probable.
A market withdrawal occurs when there isn't a violation that could lead to charges from the FDA. In this case, the manufacturer might pull the product from the market and then correct the problem before returning the product to the market. Correction and reintroduction might not occur.
Medical devices can be the subject of a safety alert. This is done when there are serious safety concerns related to a specific product.
Patients who are harmed by drugs or devices that are covered in these recalls might opt to seek compensation. This can help to cover expenses related to the effects of the drug or device.
Source: United States Food and Drug Administration, "Safety," accessed July 25, 2017