Recall manager: More device and pharma firms dealing with multiple recalls at the same time

For drug and device companies, a product recall is bad. Dealing with multiple recalls at the same time is worse. Trying to manage either scenario without a plan is nightmare territory.
That’s what ExpertRECALL wanted to illustrate during a mock recall held last month in Indianapolis. The company devoted a half-day of the Bio/Pharmaceutical and Medical Devices Recall Summit to walking drug and medical device executives through a product market withdrawal exercise to illustrate the logistics and complexities involved.
The first quarter of 2013 alone saw recalls of 315 medical devices and 107 pharmaceutical products, according to the quarterly ExpertRECALL Index, a tracking tool the Indianapolis company launched in 2011. Mike Rozembajgier, vice president of recalls for ExpertRECALL, said more companies are having to deal with several recalls at once. The company identified this trend in the most recent edition of its recall index for Q1 2013.
The most recent index noted that Q1 2013 marked the third consecutive period in which nearly 40 percent of medical device companies named in FDA enforcement reports were involved in two or more recalls. One company alone was dealing with 24 recalls, and two others had 15 each. The 107 recalls of drug and pharmaceutical products in the first quarter represented an increase of 32 percent over those in the previous quarter.
That’s why ExpertRECALL created a simulated recall that involved a fictitious product and visits to two of ExpertRECALL’s three facilities in Indianapolis, including its call center and the processing plant/warehouse facility. This gave regulators, suppliers, wholesalers and distributors a firsthand look at the decision-making process during a recall as well as the communication process for those decisions.
The best way to handle a recall — something ExpertRECALL walks clients through from start to finish — begins with drafting and testing a plan, Rozembajgier said. Companies need to get key staffers familiar with the plan so that if it needs to be implemented, it can be done with minimal confusion and risk to consumers.
In the event of an actual recall, ExpertRECALL manages all necessary components of executing that plan for clients, Rozembajgier said. This includes sending out public notifications, removing a product from the market, setting up a call center and briefing phone operators to handle complaints, receiving and storing returned products, assuaging complaining consumers, and separating and storing product returns that meet a recall’s date, label and identification number specifications from those that do not.
For example, Rozembajgier said, a manufacturer of a multi-flavored over-the-counter medicine may issue a recall for only cherry flavored products produced and marketed during a specific time frame with certain serial numbers. In the confusion of communicating a recall, returns include other flavors of the medicine, or cherry-flavored medicines produced or marketed outside the specified date range or containing ID numbers not covered in the official notification.
Companies without a plan in place aren’t prepared for the high volume of customer response that comes with a recall, probably the most eye-opening aspect of a recall process for many companies, Rozembajgier said. Medical device recalls in particular can create significant concern among consumers, driving a high amount of traffic to call centers and websites.
“This increase in response could potentially bring down these communications channels at a time when consumers need them the most,” he said. “The last thing you would want would be a customer not to be able to access the info or have a question answered.”
Companies must make sure phone lines and web servers can ramp up to handle this volume so that accurate, up-to-date and reassuring information is available at every point of the recall process, he said.
ExpertRECALL has been helping companies with recalls since 2003, when it emerged after parent company Stericycle, a disposal service for medical and bio-hazardous waste, entered the reverse logistics industry and acquired NNC Group, which handled pharmaceutical product recalls.
ExpertRECALL has handled more 3,000 recalls of various consumer products. In 2004, it assisted with the recall of Merck’s Vioxx.