ABSTRACT
Recalls of regulated product generally mean that the product became adulterated or misbranded while in the market; alternatively, the product distributed could be counterfeit, subjecting the product not only to a recall but also to other regulatory sanctions discussed in subsequent chapters. When a company discovers that a product it has placed into interstate commerce has become adulterated or misbranded, it is the responsibility of that firm to remove the product from any and all sources that received it. The health hazard seriousness or class of the recall will determine the actions taken. Recalls must be communicated to the public and healthcare practitioners, as well as, in some instances, internationally. Frequently, recalls are voluntary; however, if a sponsor or distributor has not taken steps to remove such product voluntarily, a FDA-requested recall may be demanded. This chapter examines the FDA’s statutory recall authority, recall types and classes, recall communications, FDA recall effectiveness monitoring, recall strategy, public notification, status reports, recall termination, regulated product withdrawals, and other pertinent recall facts.
