Recalls are actions taken by a firm to remove from the market any product that is in violation of laws administered by the FDA. Recalls of a drug may be conducted on a firm’s own initiative or by FDA request. A recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products. Under the FDA’s Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, manufacturers must establish and follow written procedures to facilitate the recall of defective products from the market
