Drug Recall: Understanding Its Types, Classes, Levels, and Examples

When did companies announce the drug recall?

Companies announce drug recalls as soon as they become aware of a problem with their product. As a result, prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful.

Several reasons may cause a drug to be recalled.

A recall may be issued if:

• Drug product has health hazards to patients: e.g., Vioxx was voluntarily recalled by Merck in September 2004.
• Drug product has potentially been contaminated: e.g., during production or distribution.
• The drug product is poorly packaged or mislabelled:
• The drug product is poorly manufactured: Sometimes, manufacturing defects related to a product’s quality, purity, and potency may be ignored during manufacturing, which may later cause a drug recall.

There are three main types of drug recalls:

Market Withdrawal:

This occurs when a product has a minor violation that would not be subject to FDA legal action. The manufacturer removes the product from the market or corrects the violation.

Correction Request:

This occurs when a product has a minor violation that would not be subject to FDA legal action, but the firm removes or corrects the violation in the manufacturing process.

Recall:

This occurs when there is a problem with a product that would violate FDA laws if the product were to reach consumers. A recall is a corrective action taken to remove the product from the market or to correct the problem

There are two types of drug recalls:

Voluntary Recall:

This occurs when the manufacturer or distributor discovers a problem and decides to recall the product. The FDA is notified of the recall.

FDA Requested Recall:

also called Statutory Recall. This occurs when the FDA initiates the recall. The FDA may request that a company recall a product or may order a recall if the company does not act voluntarily.

Classes of Drug Recalls

There are three classes of drug recalls, based on the level of health hazard:

Class I Recall

A Class I recall is the most severe type of recall and indicates that the use of the product poses a significant risk of serious adverse health consequences or even death.

These recalls typically involve products that are defective or have serious safety concerns.

Class II Recall

A Class II recall occurs when the use of a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III Recall

A Class III recall involves products that are unlikely to cause any adverse health consequences but violate FDA regulations.

Levels of Recall:

The level (or depth) of product/batch recall is determined based on the level at which the products are distributed and recalled.

There are three recall levels: consumer/user, retail, and wholesale.

Consumer or User Level:

May vary by product, including intermediate wholesale or retail levels. Consumers or users can be individual consumers, patients, doctors, or hospitals.

Retail Level

Remember the level immediately preceding the Consumer or User level. This includes establishments such as food retailers, pharmacies, hospital pharmacies, home pharmacies, clinics, and nursing homes.

Wholesale Level:

All distribution levels between manufacturer and retailer.

All Class I recalls must be implemented at the wholesaler/distributor, retailer, and consumer levels. In such cases, advertisements will be made in print or through electronic media tools. H. Newspaper, television, radio, etc.

All Class II recalls must be made at the wholesale and retail levels.

All Class III recalls must be completed to the wholesale level.

Time Lines for Effective Recall System & Rapid Alert

CDSCO suggested different timelines of recall, based on the category of risks involved.

For Class- I Recall: shall be ensured within 24 hours, and the physical recall shall be completed within 72 hours.

For Class- II Recall: shall be ensured up to 10 days.

For Class- III Recall shall be ensured up to 30 days.

Examples of Drug Recalls

In 2013 when a generic version of Lipitor, called atorvastatin, was recalled due to a serious manufacturing defect. The recall affected millions of tablets, and it was found that the medicine contained tiny glass particles. These glass particles were considered a potential health hazard, and the drug was recalled.

The United States experienced a drug recall in 2021 when sunscreen products were recalled for the presence of benzene, a known carcinogen. The recall affected several spray sunscreens. The company announced the recall after discovering that the product contained low levels of benzene, which can cause cancer with frequent use.

In March 2021, the MHRA (Medicines and Healthcare products Regulatory Agency) issued a Class 2 drug recall of certain batches of OTC (Over-the-Counter) painkillers containing codeine. The recall was due to concerns over the risk of addiction and overdose.

In January 2021, the MHRA issued a Class 1 drug recall of all unexpired batches of Emerade adrenaline autoinjectors. This was due to a risk of the injectors failing to deliver a dose of adrenaline, which could be life-threatening in the event of anaphylaxis.

In May 2019, the MHRA issued a Class 2 drug recall of certain batches of irbesartan-containing products. The recall was due to concerns over the presence of a possible carcinogen in the products.

Conclusion

Drug recalls can be a serious matter, and it is important to understand the different types, classes, and levels of recalls. Understanding the types, classes, levels, and examples of drug recalls can help us make informed decisions about the medications we take.