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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