When a prescription drug or over-the-counter medication manufacturer takes their product off the market, it’s known as a drug recall. The Food and Drug Administration (FDA), is either directly or indirectly, involved in the process to a great extent when a product is recalled.
The FDA is responsible for ensuring medications and medical devices are safe.
The FDA’s Center for Drug Evaluation and Research oversees the security and dependability of novel medications, ensuring they function properly and determining whether or not they are more beneficial than harmful. To ascertain the safety and efficacy of the medication, the FDA examines related research rather than doing direct testing on the substance. Following approval, the medication is put on the market, and the manufacturer must monitor and report any side effects related to the medication’s use. The FDA occasionally mandates that a pharmaceutical company conduct clinical studies or research on a medicine even after it is marketed.
A recall occurs when a drug is deemed unsafe for the general public.
A pharmaceutical medicine, vaccine, or medical device is recalled when the FDA or a drug maker decides it should not be sold to the general public and should be taken off the market. A perfect example is the omeprazole recall. Drug recall can happen for a variety of reasons, such as:
- A drug has harmful side effects and should not be used by the general public.
- New research indicates that a medicine already on the market is too dangerous for consumers to use and should be removed.
- The FDA has determined that there is a safer alternative to using pharmaceutical drugs.
- Improper or excessive use of the drug by consumers has resulted in serious injury or death.
Types of Recalls
Recalls of drugs are categorized based on the degree of danger or the reason for the risk. The following are the five primary categories of drug recalls:
- Class I Recall
If there is a real chance that using a prescription drug could result in major health problems, accidents, or even death, then this is a class I recall.
- Class II Recall
A class II recall happens when there is a slim chance that a pharmaceutical drug could result in a serious health injury or when there is a chance that using the medicine could cause mild, transient, or reversible health difficulties.
- Class III Recall
A class III recall happens when there is little chance that a medication would significantly impact health, yet the product still doesn’t comply with FDA requirements.
- Market withdrawal
When a manufacturer takes a product off the market because of a problem that the FDA would not typically watch over, this is known as a market withdrawal. A market withdrawal may happen if a certain batch of medication or product is contaminated or subjected to tampering during manufacturing.
- Medical device safety alert
Similar to the situation when a pharmaceutical drug may potentially cause harm, a medical device safety alert may be issued if there is a chance that the device could cause harm or significant injury.
Different ways that recalls can occur
A drug recall can happen in one of three ways: the most common scenario is when a manufacturer orders the recall of a product directly; another scenario is when the FDA orders a manufacturer to remove their drug from the market after finding the drug to be defective; and the third scenario is when the FDA orders a manufacturer to remove their drug from the market after the manufacturer refuses to cooperate with the FDA’s requests. In the latter scenario, a non-compliant manufacturer may face legal action from the FDA.
When a medication is recalled, customers may be notified directly by the FDA or the product maker, or they may learn about the recall through public announcements or media coverage.
