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Your Guide to Medication and Medical Device Recalls

The manufacturer is still legally responsible for injuries when a drug is recalled

The United States Food and Drug Administration (FDA) has an important mission. This agency is tasked with making sure that medications and medical devices are safe and effective. Unfortunately, not every medication or medical device that receives FDA approval is safe. Sometimes, dangerous problems arise after the agency has given its approval for a specific drug or medical device. Then, the pharmaceutical company may voluntarily issue a recall or the FDA may order a recall or warning.

Not All FDA Drug Recalls Are the Same

The FDA uses different types of recalls. These recalls include:

  • Class III recalls. This is the least serious type of recall and may be used when using the drug or medical device is not likely to cause any negative health consequences.
  • Class II recalls. This is the intermediate level of FDA recalls and may be used when the drug or medical device is likely to result in temporary or reversible negative health consequences or when the chance of a serious adverse health effect is minimal.
  • Class I recalls. This is the most serious recall the FDA can impose and it is used when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
  • Market withdrawal. This happens when a medication or medical device has a minor problem. For example, if a specific batch of a medication has been tampered with but there is no overall safety concern, then the specific batch of the medication may be subject to a market withdrawal.
  • Safety alerts. These are issued when there is an unreasonable risk of significant harm to a patient from a specific medication or medical device. In some cases, these alerts are also considered to be recalls.

Additionally, the FDA may issue a warning instead of a recall in some situations. As with recalls, the FDA has different types of warnings it may use to inform doctors and patients of potential risks. The most serious warnings are called black box warnings. The FDA requires a black box warning when a drug potentially has serious or life-threatening side effects. It is the final step before the FDA pulls the drug from the market. A pharmaceutical company that is required to include a black box warning on a specific drug is also required to develop a medication guide for that drug to provide more details about the risks for doctors and patients.

How Will You Know About an FDA Recall?

There are two notification systems that are used to communicate with doctors and the public. Those notification systems are the Recall Alert System and MedWatch.

In addition to these recall notification systems, you can also stay informed of official recalls by:

  • Monitoring the FDA website. Information about recalls and warnings can be found on the site.
  • Setting up a Google Alert or other notification. Just enter the medication’s name and any news related to the medication should be emailed to you.
  • Keeping regular doctor’s appointments and asking questions. Ask your doctor to check for any safety updates or new guidelines prior to refilling your prescription.

It is important to know if a recall has been issued, and it is important to know what to do if your medication or medical device has been recalled.

What a Drug Recall Means to You

When the FDA recalls a drug or medical device, the manufacturer can still be held accountable for injuries caused by that drug. The recall is not a legal shield for the pharmaceutical company. Thus, the absence of a recall or black box warning should not stop you from pursing legal action against the pharmaceutical company if you’ve been hurt.

You can learn more about your rights and about tips for protecting your pharmaceutical class action claim by scheduling a free, no-obligation consultation with one of our experienced attorneys. To learn more, please start a free chat or call us at 1-800-800-5678 today.

Jason F. Abraham
Managing Partner, Hupy and Abraham

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