Role Of FDA In Recall Notification

Category: Blog

A drug recall is the most efficient way to protect the public from defective or potentially harmful products. Companies that manufacture food items, cosmetics, or drugs have to annul their products if the Food and Drug Administration (FDA) issues a recall. FDA monitors the recall procedure and consults with the company regarding the effectiveness of the recall and whether the products are safe to be placed back on the market.

“Annual product recalls by the FDA rose by 92.7% from 2012 to 2017, according to a consulting industry.”

Let me give you a brief idea about how the FDA issues a recall to a company.

They begin the procedure when experts learn that a product which they regulate may be a risk to public health. The FDA investigates the unfit products in many ways:

  • The production company discovers a defect in their products and contacts the FDA.
  • FDA receives reports of a health problems from a particular product.
  • The Centers for Disease Control notes a trending health problem related to an FDA-regulated product.
  • When the employees inspect a factory and discover that there is a likelihood of manufacturing a faulty product.

Once the FDA has confirmed the defects of the products, then a recall is mandatory. The FDA and manufacturer ensure the withdrawal of the stockpile from medical stores, hospitals, and doctor’s clinics. Mostly this happens without giving any notice to the public. The FDA alerts the media during the severe cases where the potential harm from the product is “hazardous.” However, information regarding recalled medical products is accessible on the FDA’s website.

Now that you have an idea about the FDA’s reasoning for a product recall. Let’s take a deep dive into product recall classification:

  • Class I Recall
    Products that cause severe injury or even death.
  • Class II Recall
    Products which may lead to severe injury or temporary illness.
  • Class III Recall
    Products which defies the regulations of FDA and probably causes injury or illness.

To know more about recall issues let me give you an example:

The Center for Biologics Evaluation and Research (CBER) is a division of the Food & Drug Administration (FDA), which look after the human cells and tissue-based products. CBER raised their concerns related to the products developed by a biotechnology company and informed the company regarding possible adverse reactions due to its utilization in stem cell therapy. They instantly discontinued shipment of all products due to the possibility adverse effects. To add to this, they also voluntarily recalled the products they may have distributed.

A recall is essential to keep the public safe from hazardous effects of medical products.

Although people try to be careful consumers, anyone may end up buying a recalled product. If you discover such products, then don’t panic. Read the reason behind the recall; it is possible that the product poses a danger to pregnant women or immune compromised patients or some other narrow segment of the population. If the recall is regarding a drug, immediately call the doctor to find out whether you should keep taking the medication or if you will need a new alternative medicine.

Here are some roles of the FDA to keep you, and your loved one’s safe from the harmful effects of recalled drugs:


  • Alerting the public
    Mostly all the recalls are announced on the FDA’s official website or in the news. Broadcast of public recall notification occurs when a product has a Class I recall which poses a severe health hazard. However, if a company does not step up in issuing public information of a recall, the FDA may do it to protect the public. Moreover, patients can also learn about the recalled product from the manufacturer, their health care professional or pharmacist.
  • Quarantine the recalled products
    They make sure that the non-perishable products like pills or cosmetics are in a quarantine zone to keep them away from the public. Moreover, products which are perishable like meat or vegetable products are thrown away or buried.
  • Reporting of enforcement
    FDA enforcement report shows the weekly posts of recalled products. Ongoing recalls that have not been classified are also published in the enforcement report by the title of “not yet classified.” Enforcement report updates occur after the determination of recall classification.
  • Determining the effectiveness of the recall
    The FDA evaluates the effectiveness of a recall by examining the company’s efforts to warn consumers and curb the defective product from the market. If a recall seems ineffective, the FDA may request that the company take additional actions to eradicate the faulty products.

Hence, the role of FDA is vital for consumers’ health. So, always stay updated about the medical products that you use on a daily basis. Furthermore, verify that the therapies performed by the medical clinics are FDA approved. Otherwise, it may cause a long-lasting pain or even worse.

Regen America is a regenerative medical service provider. They have an expert team of doctors to help you cure your injury or disease. Then what are you waiting for? Contact Regen America and book your appointment today.

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