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Study- Drug Recalls May Go Unreported

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Laura Hosford-Yunker5 years ago

A recent report, published in the Archives of Internal Medicine, found that many “Class I”  drug recalls go undetected by doctors and other medical professionals. Researchers outline the possible reasons for this miscommunication of information.

“Drug recalls in the United States are common and often involve serious defects that pose health risks to patients,” the Epidemiology of Drug Recalls in the United States.

What is a Class I Drug Recall?

The U.S. Food and Drug Administration (FDA) defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

“Class I” is the highest rating for danger by the FDA. Class I recalled drugs are the most dangerous drugs recalled because they may pose a serious threat to consumers.

About the Study

“Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety,” study authors.

Researchers looked at 1,700 drug recalls issued between 2004 and 2011; 91 of these were Class I recalls. They found that:

  • The FDA did not issue a Recall Alert System notice for 36 of the Class I recalls (40%).
  • Of these 36- half (18) were communicated through the MedWatch and the other half (18) were not communicated through either system.
  • Researchers concluded that the problem is a combination of lack of reporting on the part of the FDA and confusion about recalls which are reported through the Recall Alert System- namely the mix of serious recalls and other recalls that have “little or no bearing on patient care” (ex: veterinary recalls).
  • Researchers are calling for a new strategy for notifying doctors about recalled drugs.
Contact an Experienced Drug Recall Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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