Recalls, Shortages and Certificates
OC administers the drug recall program, the drug expert certificate program and coordinates any incidents among OC teams.
A recall is the removal of a product from the market. In the United States, recalls are not mandated by any regulatory body, they are voluntary actions recommend by the government. When a company files a NDA with the Agency, it provides commitments on what it will do if its product is defective in any way -- the company has a responsibility for the product. If a company refuses to recall a product and there is cause, FDA can seek legal action to have the product removed from the market. A recall can have serious repercussions for both the consumer and the company.
However, the ultimate goal of a recall is to protect the consumer and to avoid any health risks.