Definitions
Class I Recall – A situation where reasonable probability exists that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 5(NYSAM – Food Recalls Guidance Document, November 2007)
Class II Recall – A situation in which us of, or exposure, to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 6(NYSAM – Food Recalls Guidance Document, November 2007)
Class III Recall – A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 7(NYSAM – Food Recalls Guidance Document, November 2007)
A recall is initiated to remove the product from commerce when there is a reason to believe it may be adulterated or misbranded. 4(NYSAM – Food Recalls Guidance Document, November 2007). The recall classification assigned to a product indicates the degree of health hazard presented by the recalled product.
Import Alert – Information to the FDA district offices concerning unusual or new problems affecting imports which give background and compliance guidance information for each product and problem.
Product recalls and/or Import Alerts include but are not limited to microbiological contaminants (Salmonella, Listeria, E.coli, etc.), undeclared allergens, banned antibiotics, uneviscerated processed fish, lead contaminated product and packaging, unapproved colors (non FD&C certified colors), unapproved sweetener sodium cyclamate, undeclared preservatives, mycotoxins, shelf stability, pesticide residues, economic adulteration, and the lack of English labeling.
Class II Recall – A situation in which us of, or exposure, to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 6(NYSAM – Food Recalls Guidance Document, November 2007)
Class III Recall – A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 7(NYSAM – Food Recalls Guidance Document, November 2007)
A recall is initiated to remove the product from commerce when there is a reason to believe it may be adulterated or misbranded. 4(NYSAM – Food Recalls Guidance Document, November 2007). The recall classification assigned to a product indicates the degree of health hazard presented by the recalled product.
Import Alert – Information to the FDA district offices concerning unusual or new problems affecting imports which give background and compliance guidance information for each product and problem.
Product recalls and/or Import Alerts include but are not limited to microbiological contaminants (Salmonella, Listeria, E.coli, etc.), undeclared allergens, banned antibiotics, uneviscerated processed fish, lead contaminated product and packaging, unapproved colors (non FD&C certified colors), unapproved sweetener sodium cyclamate, undeclared preservatives, mycotoxins, shelf stability, pesticide residues, economic adulteration, and the lack of English labeling.