Product recalls are more common than ever. We see recall announcements virtually every week. Consumers have come to expect them, and to expect that companies will act quickly and decisively when a product risk is identified. Most recalls today are voluntary and move very rapidly. Here are some observations about 2013 recall trends.
Pharmaceutical/Drug. Pharmaceutical recalls spiked to their highest recent level, according to available data and a report by ExpertRECALL. There were 348 recalls of pharmaceuticals in the first half of 2013, involving more than 30 million units. In the second quarter, 22 recalls were classified as Class I, the kind involving the greatest risk to human health. The Food and Drug Administration (FDA) defines a Class I recall as one in which there is a reasonable probability that the product will cause serious adverse health consequences or death. All of the Class I recalls in the second quarter involved prescription medications.
Medical Device. There were 726 recalls of medical devices in the first half of 2013. These affected 28.6 million units. Nearly half of the recalls in the second quarter affected medical devices sold worldwide. Eighty percent of the recalls were classified as Class II. The FDA defines a Class II recall as one in which the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls, particularly those relating to children’s products. In the first half of 2013, there were 151 consumer product recalls plus 27 that related to children’s and infant products. The main causes of the latter were hazardous materials, entrapment or strangulation. Consumer product recalls were most common with home furnishings and fixtures, sports and recreational equipment, toys and personal use items.
Food. Food recalls have involved more than 13 million food items so far in 2013 in 608 recalls. About one-third of those affected customers on a nationwide scale. Over 70 percent of those food items were classified as a Class I recall, the most serious type. Allergens were the most common cause of food recalls. Foreign materials in food also caused more recalls than in the past.
Meat and Poultry. The United States Department of Agriculture (USDA) regulates meat, poultry and processed egg products. There were 42 recalls of these products in the first half of 2013. Most of those were Class I. As with other kinds of food, undeclared food allergens caused most of the recalls. The USDA has become more active in reviewing labels and formulations related to allergens.
With recalls so widespread and speedy, how can companies that bring products to people best prepare?
Recall Readiness Plan. One of the greatest dangers to a product manufacturer or seller is not moving quickly enough to recall a product. Some of the largest regulatory fines and penalties have been levied due to a company’s delay in recalling a product after it finds a risk or problem. The need for speed should not be underestimated.
For any business that makes or sells products, a recall readiness plan is essential. Here are a few basics to get a plan rolling:
- Most likely scenarios. Identify your company’s most likely recall scenarios. What are your product’s risks and exposures, particularly as they might relate to human health? Contamination in the supply chain? Allergens that haven’t been identified? A change in the product’s condition due to environment? Placement or installation problems in the field? How and from where are you most likely to receive reports of a problem?
- Recall management team. Assemble your team in advance. Who will be responsible for communications with agencies, supplier and vendor partners, and the public? Who will be your root cause investigator, gathering the scientific facts and analysis? Who will handle replacement products? Who will track product return or disposal? Immediate contact information for everyone is critical, as well as backups for those who may be unavailable in the vital first hours and days.
- Communications plan. Gather key contact information for agencies and supply chain partners. If you decide to establish dedicated email addresses or toll-free phone lines, how will you put those in place? What would you plan to say on your website? Track down sample press releases and consider how you would modify them for your product and business.
A recall readiness plan need not take a great deal of time or effort, but will put a framework in place should your business face a recall or potential recall situation. Preparation will help your company act quickly and responsibly, which in turn helps to protect your customers and your brand.