Product Recall or Product Withdrawal
11-13-2009
By Mike Rozembajgier
Nearly every day we hear news about a product being pulled off the shelves. More often than not, the media defines this negative news as a product recall. However, the Food and Drug Administration (FDA) differentiates these events into two separate categories: recalls and market withdrawals. But what’s the difference?
Recalls are situations in which the use of or exposure to a violative product may cause adverse health consequences or death to consumers. Market withdrawals, on the other hand, occur when a product has a minor violation that the FDA feels is important enough to remove the product from the marketplace, but which carries no FDA penalties. Despite the difference in the level of severity in these two classifications, however, consumers hear “recall.” Why does this matter and what does it mean to the companies involved with a withdrawal?
While the company faces stronger penalties for product recalls than withdrawals, the costs and brand damage have potential to be the same. It doesn’t matter how the FDA classifies the violation; our consumer instincts tell us that recalled products could make us sick or cause injury, and we become much more wary of buying that product in the future.
We cannot change the way the media reports news. Companies can, however, be prepared for the inevitable. As time passes and regulations and standards change, it becomes increasingly critical that manufacturers and retailers be prepared for both cases. Whether a product is recalled because it poses a threat to consumer health and safety, or withdrawn from the market because of Point of Purchase labeling or issues related to marketing, clearing the shelves effectively and rapidly is the best way to maintain consumer trust.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.
Do you have any statistics or estimates on the cost of recalls and withdrawals in the medical technology industry, on average? Costs of manufacturing defects in this area?