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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Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
In addition to a large and growing number of products made in Mexico and found to contain methanol on recall, sanitizers made by a Washington state dental whitening product firm contain ethanol at below labeled levels and the presence of undeclared isopropyl alcohol. Recent recalls also include injectable CBD formulations a Seattle firm marketed OTC and a New Jersey’s firm dandruff shampoo produced with water that failed US Pharmacopeia specifications