The US Recall Index, a measure of publicly announced recalls across a variety of industry sectors, showed a sizable jump for pharma in the first quarter of this year, as compared to the last quarter of 2017, according to Stericycle Expert Solutions, a service provider. While quarter-by-quarter data tend to be highly variable, Stericycle says that the cumulative total for 2017 was 325 recalls, up 12.5% from 2016’s 289. The volume of recalled items was massively worse: over 206 million items, up 350% over 2016’s 46 million.
“Recalls” are a specific type of product return—those that have some type of flaw, ranging from mislabeling to contaminated ingredients. Generally, pharma companies conduct voluntary recalls in collaboration with FDA (there is a reporting requirement to FDA for any recall). Companies like Stericycle are tasked by manufacturers with alerting the supply chain, from wholesalers to pharmacies—and even patients in some cases—and collecting the off-spec items. According to the Stericycle Index, nearly all the Q1 2018 recalls were due to deviations from Good Manufacturing Practices (GMPs)—which points directly at manufacturing miscues. On the plus side, only 1.3% of recalls were rated as Class III, the most severe, highest-risk type.
Mike Good, VP of marketing at Stericycle, says that one change manufacturers have instituted in recent years is to limit the size of product lots, from a few million to a few hundred thousand; since recalls are dictated by lot sizes, this can reduce the volume of a recall. Overall, however, recalls are simply a fact of life for pharma manufacturing, and companies should approach the task proactively by preparing for an eventual recall, running mock recalls (which often have an urgent time element to them) and coordinating their supply chain activities with the recall-management firms they might use. “Failing to prepare is preparing to fail” a recall, quips Good.