Why Recalls Happen
Are taking a prescription medication that has been recalled? A drug recall is announced the U.S. Food and Drug Administration (FDA) or the manufacturer. It takes an over-the-counter or prescription drug off the market. It can no longer be sold. A drug recall occurs when the manufacturer or the FDA determines certain criteria have been met. Often, the threat of legal action will also prompt a drug recall. The recall will happen when a drug is found to be either potentially harmful or defective. If a manufacturer discovers something wrong with their drug, they may do a voluntary recall.
Reasons for Recalls
There may be a number of reasons why a drug is recalled. A drug recall may be issued for a particular drug if:
– The drug is packaged poorly or mislabeled. There are times when the packaging includes confusing instructions for dosing or if the drug includes a dosing tool, there is a problem with the instrument.
– The drug is determined to be a health hazard. When a drug reaches the market, possible health issues may not be noticed until the drug has been in use for a while.
– The drug has manufacturing defects. These may impact the drug’s purity, quality or potency.
– The drug’s packaging incorrectly labels the drug. For example, you purchase a drug that says it is a pain reliever on the packaging, but when you open the box, there is something else inside.
The most common type of drug recall is a manufacturer recall. This is typically done because a drug has been discovered to be unsafe. Most of the time, this occurs after the drug is released. The company will get complaints from customers or patients or may pull the drug following a research study or a clinical trial. The company will usually determine that the drug may cause serious complications or there was a manufacturing problem that could risk a patient’s safety.
Who Does What in a Recall
During a drug recall, the manufacturer and the FDA work closely together. There is an FDA database that tracks all drug recalls. The public has access to this database and can help companies pull their drugs from the market when necessary.
There is a classification system for a drug recall. Each class represents the severity of the problem. The FDA announces a mandatory drug recall if the company doesn’t voluntarily recall the drug. The FDA only does this on rare occasions, but it is a powerful incentive for drug companies to remove one of their drugs from the market if there is a problem.
There are times when a drug company may determine a drug should simply be withdrawn from the market. This is called a market withdrawal and differs from a drug recall. When this happens, drugs currently being sold do not have to be returned. The company simply stops selling the drug which results in a gradual removal instead of an abrupt recall.
A drug recall is a serious step and is only done when there is a problem with a drug. When a drug is recalled, all product must be removed from store shelves and the manufacturer must stop distribution.