Source : 'HBW Insight'
The number of containers of pharmaceuticals recalled in the US during the third quarter nearly doubled from the second quarter to nearly 33.8m as recalls increased nearly 50%, says Stericyle Inc.
OTC hand sanitizers containing methanol accounted for a large part of the total and likely will continue frequent recalls in 2021, according to the firm which consults on planning and conducting recalls with manufacturers across, pharmaceutical and medical device products and other consumer packaged goods categories.
“From a product category perspective, safe hand sanitizers remain a priority,” says Chris Harvey, crisis solutions vice president in Stericycle's Expert Solutions unit.
In response to HBW Insight questions, Harvey noted announcements that the Food and Drug Administration continues finding contaminated or subpotent OTC hand sanitizers available in the US since soon after the agency loosened regulations on manufacturing the products in order to boost supplies as consumer demand soared in response to COVID-19. ()
“As long as hand sanitizers are considered an important product in not only preventing the transmission of coronavirus but also an essential part of overall hygiene, don't expect this topic to fall from FDA's priority list,” he said.
Stericycle’s recently published “Recalls Insights Report” for the 2020 third-quarter states that recall activity in the July-September period increased 49.3% from the April-June period, reaching 100 events for the first time since the 2018 fourth quarter, despite “minimal inspection activity in the third quarter.”
The jump in recalls drove a 92.7% increase in impacted units to 33.8m even with FDA’s facility inspections limited to virtual visits.
The report points out while 336 drug recalls were reported in the US in 2019, through the 2020 third quarter the industry and the FDA had reported 260 events, averaging about 87 per quarter.
Stericycle says “with the fourth quarter historically seeing among the highest recall levels four of the last six years, it’s more than feasible to think we could surpass last year’s total recall volume even during a year best known for a global pandemic.”
The Bannockburn, IL-based firm’s report provides analyses and perspective on trends affecting product safety regulation across industries it tracks. To streamline its clients’ product recall processes, it manages notification and response, processing and tracking and compliance and reporting.
Harvey said for hand sanitizers and other OTC products, Stericycle found good manufacturing practices deviations accounted for 31.1% of recalls over the past year.
But differences in “lead causes” were reported across different categories. While the primary reason for hand sanitizer recalls was GMP deviations, followed by contamination and subpotency, mislabeling is the leading cause of recalls among pain relievers and superpotency among lip balms.
Contaminated hand sanitizers aren’t the only consumer health products recalled during 2020 due to reasons linked to the coronavirus pandemic. Numerous products that the FDA, often working with the Federal Trade Commission identified as marketed with fraudulent claims to prevent or treat COVID-19 also have been recalled. ()
Harvey said COVID-19-related fraud will remain among the FDA’s top priorities in 2021, and growing consumer demand for OTC at-home diagnostic tests likely will generate additional false claims for products subject to the agency’s oversight. ()
“Expect the FDA to have a continued focus on GMP, especially when it comes to foreign [active pharmaceutical ingredient] manufacturers. It is critical for manufacturers, especially during this global pandemic, to be even more diligent with ensuring suppliers are meeting standards and quality requirements,” he said.
“COVID-19 fraud is also a hot-button issue that isn't going anywhere. … As at-home COVID-19 testing kits become more available, and consumers continue to look for ways to protect themselves or recover from the coronavirus, fraud will remain a top priority.”
By Malcolm Spicer