Blanket Warning By US FDA For Sanitizers Made By Mexico Firms Linked To Methanol Contamination
The agency’s latest in a series of increasingly strident announcements expands its its warning not to use any hand sanitizers from the firms linked to methanol contamination “even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”
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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.
HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.
More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.