Product recall Class II

Class II recall is the situation in which use 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. It is preventative in nature and issued if there is no immediate danger of death or other serious injury linked to the product.

Examples of Class II recalls include
*Botulinum potential and Norovirus contamination in seafood
*The presence of undeclared dry milk as an ingredient in sausage,
*A food that contains yeast or mold contamination
*Candy with FD&C #5 yellow dye not listed on the label
*Metal shavings in a canned food.

FDA recall classifications are designed to help companies identify and resolve product defects before they cause additional, unnecessary harm consumers. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Product recall Class II

Class II defect: major

Defects are classified into three main categories – minor, major and critical. Major defects in canned foods : Defects that result in cans which do not show visible signs of having lost their hermetic seal, but are of such magnitude that they may have lost their hermetic seal.

This is a major defect rating which may result in the loss of the hermetic seal and become a public health problem. Some container defects can increase the potential for microbiological contamination of canned foods resulting in spoilage and in some instances in foodborne illness. While some of these defects are hidden, many are visible on the container surfaces permitting their detection without destructive analysis.

Control of such defects, that is preventing their occurrence, is exercised in a number of critical control points in the GMP's to assure that the risk of post-process microbial contamination which may result in spoilage and food poisoning is minimized.

Major defects are considered those which could adversely affect performance of the product. Such a defect would likely cause a customer to return the product.
Class II defect: major