Overview of FDA Recall Process for Defective Products & Drugs (Part 3)

Overview of FDA Recall Process for Defective Products & Drugs (Part 3)

FDA recalls can be classified as class I, class II or class III recalls based on the severity of the risk a product or medication poses to the public.

FDA recalls can be classified as class I, class II or class III recalls based on the severity of the risk a product or medication poses to the public.

Concluding the three-part blog on the Overview of FDA Recall Process for Defective Products & Drugs, the following is some important information about the types (or classes) of FDA recalls that may be issued for defective products and dangerous medications. These FDA recall classes are broken down into categories based on the level of risk or harm they pose to the public. Specifically, the FDA recall classes include:

  • Class I FDA recalls: This is the most serious type of FDA recall that can be issued, as it indicates that use of the product or medication can cause serious health complications and potentially even death. One example of a class I FDA recall issued within recent years is the recall that was issued for hip implant devices.
  • Class II FDA recall: Also serious in nature, this type of recall indicates that use of a product or medication may cause temporary or treatable health complications and/or that the product or medication in question may have a low risk of causing severe health complications.
  • Class III FDA recall: This is the least serious type of FDA recall in that it indicates that use of a product or medication will likely not have a negative impact on public health.

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