OTC Sanitizers Lather Up US Drug Recalls In 2020
OTC hand sanitizers containing methanol accounted for a large part of the total and likely will continue frequent recalls in 2021, according to Stericyle. "From a product category perspective, safe hand sanitizers remain a priority,” says VP Chris Harvey.
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Widespread findings in the US of methanol in OTC hand sanitizers labeled as containing ethyl or isopropyl alcohol are not without precedent as adulteration affecting a specific type of product. But surging sales hand sanitizers, sub-potent formulations as well as methanol-contaminated, prompted more immediate and comprehensive responses from FDA.
FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.
Attorneys for Combe tell HBW Insight that the USPTO appeal board’s decision recognizes the marketplace power of a popular brand like Vagisil. Marke Enterprises' proposed Vagisert trademark for similar product was rejected.