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What is the difference between Market withdrawal and Product Recall
3 Jul 2015

What is the difference between Market withdrawal and Product Recall?

Product Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.  A product recall removes products from distribution, sale or consumption that present a significant health or safety threat because of a product defect or contamination. This can either be at trade or consumer level. Recalling food products can happen because of a report or complaint from manufacturers, wholesalers, retailers, government or consumers. It can also occur after the business itself has run internal tests and audits.

Market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
A product withdrawal, on the other hand, is where product is removed from the supply chain — but not for health and safety reasons. For example, if something has been labelled with the wrong weight, the manufacturer may want to withdraw it. But if that same product was labelled with the wrong ingredients and allergens, this would then be a recall. Manufacturers sometimes also withdraw products as a precaution, waiting further investigation of a potential public health risk. If that risk is established, the food must be recalled.

KPE-C-103 Executive Program in Global Drug Regulatory Affairs [EPGDRA]

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