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What is a “Recall Strategy” as defined by the FDA?

It’s a strategy that covers critical factors related to recalling a product:

Here are the basic elements of a strategy:

(i) Results of health hazard evaluation.

(ii) Ease in identifying the product.

(iii) Degree to which the product's deficiency is obvious to the consumer or user.

(iv) Degree to which the product remains unused in the market-place.

(v) Continued availability of essential products.

 The basic elements of a recall strategy are:

Dept of Warning: 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

Public Warning: The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health.

Effectiveness Checks: The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.