Recalls are actions taken by a firm to remove the market any product that is in violation of laws administered by FDA. Recalls of a drug may be conducted on a firm’s own initiative or by FDA request. A recall is an alternative to an FDA-initiated court action for removing or correcting violative, distributed products (see 21 CFR 7.40(a)). Under FDA’s CGMP regulations for finished pharmaceuticals, manufacturers must establish and follow written procedures to facilitate the recall of defective products the market
