Recall process for defective medical drugs | Bart Durham Injury Law

Recall process for defective medical drugs

The United States Food and Drug Administration oversees the approval of medical drugs, many of which are commonly used by Nashville residents. When a drug is found to be a dangerous product that violates FDA regulations, it is recalled.

Recalls can either mean the removal or correction of a product. In a removal, all affected products are taken to another location. In a correction, the products are destroyed or repaired. 

Recalls can be conducted by either the FDA or the drug’s firm, and under some circumstances a firm may be required to report a recall to the federal agency. When this occurs, the FDA will make a determination regarding the type of risk the product poses using its classification system, which has three categories:

  • Class I. These recalls are for the most serious and dangerous drugs. These products have a reasonable likelihood of causing death or severe health consequences.
  • Class II. Drugs fall under this category if they pose risks of temporary or reversible adverse health problems. The chances of these drugs causing serious health problems are unlikely.
  • Class III. Products that are not likely to lead to adverse health consequences are placed in this category.

The FDA will also advise the company on how to conduct the recall, which may involve a discussion of how the public should be warned about the defective drug. The firm’s handling of the recall may also be monitored and audited by the federal agency.

According to FindLaw, if a consumer has suffered an injury due to the use of a defective drug, that person may have the right to bring a product liability lawsuit against the pharmaceutical manufacturer.  

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