Recalls, Shortages, and Certificates
OC also administers the drug recall program. A recall is the removal of a violative product from the market. In the United States, FDA does not have "mandatory" recall authority, so all recalls are voluntary actions taken by the firms, though in some cases FDA will "request" a recall and use the media to make consumers aware of products that should be returned to the manufacturer. When a company files a NDA with the Agency, it takes on the responsibility to comply with regulatory requirements for recalling defective products. If a company refuses to recall a product, FDA can seek legal action to have the product removed from the market. However, product removal can have serious repercussions for both the firm and consumers, and would generally not be as timely or efficient in protecting the public than a voluntary action taken by the firm.
In the case of foreign manufacturers, FDA can also issue an import alert that prevents a violative or uncooperative firm's products from entering the United States. During a recall, the OC provides assistance to the firm recalling a product and the FDA district office. While the district office is responsible for collecting all the information for the recall, and the firm has the responsibility to perform the recall and any related investigation, the OC provides guidance on what needs to be done, what the company should be doing and the type of information needed.