Market withdrawal is described as what?

• A. A major safety recall with FDA enforcement action.
• B. A minor violation not subject to FDA action; the firm removes the product or corrects the violation.
• C. A safety alert for medical devices.
• D. A recall due to manufacturing defects.

Answer: (B)

Market withdrawal refers to removing a product from the market for a minor issue that does not pose a health risk to patients. It is a voluntary action by the company and not subject to FDA enforcement. The firm either withdraws the product or corrects the issue—such as labeling or packaging—without any safety concern requiring formal recall processes. This is different from a recall, which involves a safety risk or defect, and from safety alerts or notices that address potential hazards.