Rampant adulterations in specific categories previously have hit US drug ingredient supplies, but none threatened the safety of a type of product soaring in demand due to a public health emergency or prompted an import alert imposed on an entire country.
FDA, USP ‘Walk Companies Through The Basics’ Of GMPs After Widespread OTC Sanitizer Adulteration
Threat To Safety Across A Drug Category In US Has Precedent, But Not During A Pandemic
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.
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