What to Know About FDA Recalls of Prescription Drugs

Each year, there are thousands of new medications approved for public use. However, there are times when issues are discovered with medications that are currently on the market. Sometimes, the problems discovered with the medication can lead to a recall so that the medications are no longer available for purchase and consumption. Here, a Louisville medical malpractice lawyer discusses the FDA prescription drug recall process.

The FDA’s Role in Recalls

The US Food and Drug Administration (FDA) remains firmly in charge of medication approvals in the US. They state that the most effective way to protect individuals from harmful products is to initiate a drug recall. Recalls are voluntary actions taken by companies to get a defective prescription or over-the-counter medication off of the shelves. Drug recalls can be initiated by the company on their own or at the request of the FDA.

The role of the FDA during a drug recall is to oversee the company’s strategy and to assess whether or not the recall was successful. Additionally, the FDA has three different classifications of recalls for prescription drugs:

  • Class I – At this level, this means that the medication could cause serious health problems or even death to a consumer.
  • Class II – This classification level indicates that the medication could cause a temporary health problem or pose a minimal threat of potentially serious harm.
  • Class III – This level indicates that the prescription medication is unlikely to cause any adverse health reactions, but it somehow violates the manufacturing or label laws put in place by the FDA.

Why Recall a Prescription Drug?

There are various reasons why the FDA or a prescription drug company may determine that a medication is unsafe for consumers. This can include, but is not limited to, the following:

  • Hazardous nature of the drug. The risks of a drug often do not come to light until after the medication hits the market, sometimes years or decades later. There are almost always known side effects associated with prescription medications, but it is the unknown complications that typically give rise to recalls later on.
  • Contaminated ingredients. There are times when a particular batch of medication is exposed to harmful or unwanted ingredients, which could result in consumer health risks.
  • Manufacturing defect. Errors that occur during the manufacturing process of medication could result in compromised efficiency or safety for the product. This could include incorrect chemical combinations, incorrect drug quantities, the presence of impurities, etc.
  • Labeling error. Labels are designed to keep consumers safe. Any mistake made in the labeling of a medication could result in misinterpretation by patients and lead to an adverse reaction.

How to Know if You Have a Recalled Medication at Home?

If you have any questions about whether or not the medications in your home are safe, we encourage you to visit the FDA website, which provides a search engine and filters you can use to find your particular medications.

When you go to the website, be advised that the FDA also controls and updates recalls related to foods and beverages along with prescription and over-the-counter medications. Do not be surprised if you see information regarding food recalls on that web page. You can search for your particular medication in the search bar provided by the FDA.

If you have questions, speak to a dangerous drug attorney in Kentucky today.