A recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which it would initiate legal action (e.g., seizure).
Recall Classification
Recall Classification is the numerical designation, i.e., I, II, or III, assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.
Class I Recall
Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II Recall
Class II Recall is a 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.
Class III Recall
Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, i.e., wholesaler, retailer, user/consumer, which is known as the depth of recall.
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