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What Happens When a Drug is Recalled by the FDA?

On Behalf of | Dec 19, 2018 | Legal Resources

A drug recall occurs when the manufacturer of a prescription drug or over-the-counter medicine removes a product from the market. In the event of a product recall, the Food and Drug Administration (FDA) plays a large part in the process, whether directly or indirectly. Below, the product and medical device liability lawyers at The Law Offices of Peter Angelos explain the process of a drug recall, including how the FDA monitors drugs, types of drug recalls and when drugs are deemed unsafe and are subsequently removed from the market.

The FDA is Responsible for Ensuring the Safety of Drugs and Medical Devices

The FDA’s Center for Drug Evaluation and Research is responsible for monitoring safety and reliability of new drugs, ensuring they work correctly and evaluating whether they do more good than harm. Rather than testing the drug directly, the FDA instead reviews the research associated with the drug to determine the safety and effectiveness of the drug. Once the drug is approved, it is available on the market, and the manufacturer has the responsibility of reviewing and reporting any issues connected with the drug’s use. Occasionally, the FDA requires that a drug manufacturer continue to conduct research or clinical trials on a drug while it is on the market.

A Recall Occurs When a Drug is Deemed Unsafe for the Public

A recall occurs when either a drug manufacturer or the FDA determines that a pharmaceutical drug, vaccine or medical device is not safe for public use and should be removed from the market. This can occur for any reason including: a drug causes detrimental side effects and is unsafe for public use; new research shows that an available drug is too dangerous to use by consumers and should consequently be removed from the market; the FDA has concluded that there is a safer alternative to taking a pharmaceutical drug; or that consumers use the drug improperly, or in excess, and that the unprescribed use has led to serious injury or death. In addition, a drug can be removed from the market if a manufacturing error or contamination incident resulted in a specific batch of drugs becoming unusable. This does not always mean that the drug itself is unsafe, rather that some of the batches were contaminated with an impurity or manufactured in a way that deviated from the standard.

There are Five Major Types of Recalls

Drug recalls are separated by the level of risk or the cause behind the risk. The five main categories of drug recalls are as follows:

Class I Recall:

A class I recall occurs if there is a legitimate risk that usage of a pharmaceutical drug may cause serious health issues, injury or death.

Class II Recall:

A class II recall occurs if there is a possible risk that usage of a pharmaceutical drug may cause minor, temporary or reversible health issues, or a slim risk that a drug can cause serious health injury.

Class III Recall:

A class III recall occurs when the risk of a drug causing major health consequences is improbable, but the product violates regulations established by the FDA.

Market Withdrawal:

A market withdrawal occurs when a manufacturer removes a product from the market due to an issue that the FDA would not normally monitor. A market withdrawal can occur if a particular batch of drug or product was exposed to tampering or contamination while being manufactured.

Medical Device Safety Alert:

A medical device safety alert can occur if a medical device is at risk of causing harm or serious injury, similarly to the event in which a pharmaceutical drug could cause potential harm.

Recalls Can Occur in Three Distinct Ways

A drug recall can occur when: a manufacturer directly orders the recall of a product, which is the most common form of recall; the FDA suggests to a manufacturer that they remove their drug from the market because the FDA has deemed the drug defective; or the FDA orders a manufacturer to remove their drug from the market in the event of the manufacturer’s refusal to comply with the FDA’s requests. In the latter case, the FDA can take a non-compliant manufacturer to court. Once a drug is recalled, the FDA and product manufacturer can notify consumers about the recall via a direct notification, a public notification or by media coverage.

Speak to a Lawyer at the Law Offices of Peter Angelos About Drug Recalls

While drug recalls are initiated in order to protect consumers’ health and safety, a harmful or defective drug can lead to serious illness, injury or death. The product and medical device liability lawyers at The Law Offices of Peter Angelos represent victims who have experienced the adverse effects of pharmaceutical drugs and faulty medical devices and can help you receive the compensation you deserve. If you or a loved one has been affected by a recalled pharmaceutical drug or medical device, schedule a free consultation today.